Ms. Mona
Rowe
Brookhaven National Laboratory
Building 134
Upton, NY 11973-5000
Phone: 631-344-2345
Fax: 631-344-3368
E-mail: mrowe@bnl.gov
Number of Human Subjects projects reported: 50
| BNL-96-265 | "General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects" |
| BNL-99-301 | "PET Studies of Alcoholism: Measurement of Brain Glucose Metabolism and Dopamine Activity" |
| BNL-99-302 | "Dopaminergic Brain Function in Alcoholics: Response to Methylphenidate Challenge" |
| BNL-00-324 | "PET Studies of Catechol-O-Methyltransferase (COMT) with [18F]Ro-41-0960" |
| BNL-00-325 | "PET Studies of Monoamine Oxidase (MAO)" |
| BNL-00-326 | "Brain Dopamine and Reward and Motivation in Controls and Substance Abusers" |
| BNL-00-328 | "Perception of Pleasure and Control of Behavior in Drug Addiction: An fMRI Study" |
| BNL-01-345 | "Brain Imaging Studies of Obesity" |
| BNL-01-350 | "PET Imaging Studies of Brain Dopamine: Changes in Subjects Infected with Human Immunodeficiency Virus (HIV)" |
| BNL-01-352 | "PET Studies of Cocaine Abuse: Effects of Expectation" |
| BNL-01-353 | "PET Studies in Attention Deficit Disorder: Role of Dopamine" |
| BNL-01-355 | "Blood Brain Barrier Permeability in MS Lesion Development" |
| BNL-02-364 | "Brain Dopamine, Reward and Motivation in Obese Subjects With and Without a Binge Eating Disorder" |
| BNL-02-365 | "Imaging of Neuroendocrine Tumors Using PET (COMT)" |
| BNL-02-367 | "Heavy Ion Induced Chromosome Damage and Biomedical Countermeasures" |
| BNL-02-369 | "Clinical Correlates of Longitudinal PET Changes in Alzheimer's Disease (AD): A Glucose Challenge Study" |
| BNL-02-370 | "Imaging of Brain Metabolic Responses to Food Presentation" |
| BNL-02-371 | "Botulinum Toxoid Immunization" |
| BNL-02-373 | "Methamphetamine Effects in Brain Dopamine Activity" |
| BNL-02-374 | "Clinical Correlates of Longitudinal PET Changes in Normal Aging, Mild Cognitive Impairment and Alzheimer's Disease " |
| BNL-03-381 | "Brain Metabolic Response to Images of Violent Behavior" |
| BNL-03-384 | "Sodium MRI of Brain" |
| BNL-03-385 | "Monoamine Oxidase (MAO) Genetics and Brain Function" |
| BNL-03-386 | "PET Imaging of Nicotinic Receptors" |
| BNL-03-387 | "Acoustic Interference on Attention " |
| BNL-03-388 | "Measurement of Dopamine Systems in Subjects At-Risk for Alcoholism" |
| BNL-03-389 | "Influence of the Shielding on the Space Radiation Biological Effectiveness" |
| BNL-03-390 | "Brain Dopamine Function in Adults with ADHD" |
| BNL-04-394 | "Brain Metabolic Response to Satiety Control: Effects of Implantable Gastric Stimulation (IGS)" |
| BNL-04-398 | "Medical Surveillance of Current BNL Employees Identified as Beryllium Exposed" |
| BNL-04-399 | "Imaging of Brain Metabolic Response to Mathematical Task" |
| BNL-05-400 | "The Role of Gastric Distention in Eating Behavior" |
| BNL-05-401 | "Cerebral Language Organization in Children with Autism Spectrum Disorders - an fMRI Study of Dichotic Listening" |
| BNL-05-402 | "Intramyocellular Trigylcerides Content as a Determinant of Insulin Resistance in Elderly" |
| BNL-05-403 | "Metabolite Comparison Between Venous and Arterial Blood" |
| BNL-05-404 | "Brain Metabolic Responses to Cocaine Cue in Cocaine Users" |
| BNL-05-406 | "Cerebral Language Organization in Adults with Autism Spectrum Disorders - an fMRI Study of Dichotic Listening" |
| BNL-05-408 | "Effect of Therapeutic Cocaine Vaccine on 11-C-Cocaine Brain Distribution Measured with PET" |
| BNL-05-409 | "Novel Multi-Modality MRI and Transcranial Magnetic Stimulation to Study Brain Connectivity" |
| BNL-05-410 | "The Role of Norepinephrine Transporter (NET) in Stimulants" |
| BNL-05-411 | "SND 103190: An Open-Label, Randomized PET Study in Healthy Male Volunteers Consisting of Part A and Part B" |
| BNL-06-393 | "Non-Invasive Blood Radioactivity Monitor" |
| BNL-06-413 | "Imaging Insulin Resistance in Obesity" |
| BNL-06-414 | "Neurogenetics of Inhibitory Control" |
| BNL-06-415 | "Ovarian Hormone Modulation of Intracranial Pressure (ICP): MR Study" |
| BNL-06-416 | "PET Study of Retinal Prothesis Functionality" |
| BNL-06-417 | "Acoustic Interference on Attention in Cocaine Abusers" |
| BNL-06-418 | "Novel Multi-Modality MRI and Transcranial Magnetic Stimulation to Study Brain Connectivity" |
| BNL-06-419 | "PET Studies of Modafinil (Provigil)" |
| BNL-06-420 | "PET Studies of the Pharmacokinetics of d-Methamphetamine in the Human Body" |
"General Magnetic Resonance Imaging (MRI) and Spectroscopic (MRS) Studies of Human Subjects"
Principal Investigator: Dr. Dardo Tomasi, Brookhaven National Laboratory
Project started in: 1996
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 05/19/06
IRB approval number: 20066190
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The goal of this research is to evaluate tissue magnetic resonance signal relaxivities at the 4 Tesla (4T) field strength and to conduct research aimed at increasing our understanding of the mechanisms and evolution of normal tissue function and human disease states. This work will not be used for routine diagnosis. About 300 studies, all of normal adult volunteers, are ultimately expected to be made in a year. No radiopharmaceuticals (drugs) or surgical procedures will be used in this study. Each participant will be asked to complete an entry questionnaire prior to completing a consent form and being allowed into the magnet. The purpose of the entry questionnaire is to screen out individuals who may have problems in the magnet caused by metal implants, claustrophobia, etc. During the study, the subjects will be monitored visually and communicated with via a two-way intercom from the control room where the operator is located. Because of the strong magnetic field, individuals with surgically implanted metallic devices such as clips, artificial joints, certain heart valves and pacemakers will be excluded from this study, as well as subjects with claustrophobia. The possible risks due to the magnet itself are primarily related to the slight possibility of a sensation of dizziness or nausea as the subject moves in and out of the magnet or moves their head in the magnet. The magnet is thought to be able to exert a force on the fluid within the semicircular canals near the ears, thus giving a sensation of disequilibrium. The sensations go away if the head is not in motion or if the individual is not moving in and out of the magnet. Subjects are exposed to noise from the machine, for which earplugs are provided. All records are confidential and may not be disclosed without the subject's written consent with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Alcoholism: Measurement of Brain Glucose Metabolism and Dopamine Activity"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 09/11/06
IRB approval number: 20063514
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Dopamine is a chemical compound in the brain which is important in movement and in feelings of reward and well-being. Recent positron emission tomography (PET) imaging studies have shown that dopamine activity and brain metabolism are abnormally low in alcoholics. An important question is whether these systems recover when subjects withdraw from alcohol. To do this, a PET camera will be used to visualize dopamine activity (using [11C]raclopride and [11C]d-threo-methylphenidate or [11C]cocaine as tracers) and brain sugar metabolism (using F-18-fluorodeoxyglucose (18FDG) as a tracer) in alcoholics and a comparison group of at-risk and control subjects. Imaging will be done on two different days, four to six weeks apart to assess recovery. The radiotracers used are labeled with the short lived isotopes, carbon-11 (half life: 20.4 minutes) and fluorine-18 (half life: 110 minutes). Forty alcoholic subjects, 16 non-alcoholic subjects, and 40 subjects at risk for alcoholism will be enrolled in the study in order to complete 16 in each group. The information from this study will add to our understanding of the relationship between changes in brain dopamine activity and brain metabolism and the degree to which deficits recover when alcoholics stop drinking. The use of a control population is necessary as a comparison group. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Dopaminergic Brain Function in Alcoholics: Response to Methylphenidate Challenge"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 09/08/06
IRB approval number: 20064090
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Dopamine is a chemical compound in the brain which is important in movement and in feelings of reward and well-being. The goal of this study is to find out whether alcoholics and cocaine abusers have different brain dopamine function than non-alcoholic and non-cocaine addicted subjects. This will be done with a brain imaging method called positron emission tomography (PET). A PET camera will visualize how much dopamine the brain releases and also how certain brain regions become activated in response to the injection of methylphenidate, a stimulant drug known to release dopamine. Dopamine release will be measured using a radiotracer called [11C]raclopride and brain activation will be measured using a radiotracer called F-18 fluorodeoxyglucose. Both C-11 and F-18 are radioisotopes of short half life. Subjects will be tested on two different days with both of these radiotracers. On one day, they will receive a saline solution and on the other methylphenidate. They will not know on which day they will receive the saline or the methylphenidate. Fifteen alcoholic subjects, ten normal controls, and five subjects at risk for alcoholism will be studied. The ability of the human brain to release dopamine in response to a drug challenge, as well as its ability to activate certain brain areas, is important in understanding human behavior and the mechanisms involved in alcohol and cocaine addiction. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Catechol-O-Methyltransferase (COMT) with [18F]Ro-41-0960"
Principal Investigator: Dr. Yu-Shin Ding, Yale University
Project started in: 2000
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 02/18/05
Explanation of IRB approval:
Study inactivated when PI left BNL 10/05.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
COMT (catechol-O-methyltransferase) is a natural enzyme in the body that is sometimes found in greater amounts in certain breast tumors. The purpose of this study is to determine whether the larger amounts of COMT can be seen in breast cancer with positron emission tomography (PET), a medical imaging method similar to a camera, and whether this information can be of value in breast cancer diagnosis and treatment. The procedure will involve PET scanning with a tracer called [18F]Ro41-0960, which links itself with the COMT already in the tumor. Subjects with breast cancer who are scheduled to undergo surgery will have a PET scan within two weeks preceding the surgery. The results of the PET scan will be compared with the results obtained by examination of the surgical sample, which is removed during the surgery. If PET and the experimental tracer [18F]Ro41-0960 provide diagnostic information, it could reduce the need for unnecessary breast biopsies and make current diagnostic procedures better. This study may also provide knowledge which may suggest new treatments for breast cancer. Twenty breast cancer patients will be studied up to two times each.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"PET Studies of Monoamine Oxidase (MAO)"
Principal Investigator: Dr. Joanna S. Fowler, Brookhaven National Laboratory
Project started in: 2000
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 04/15/05
IRB approval number: 20055950
Explanation of IRB approval:
Study inactivated 09/05.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
We are developing methods to image the enzyme monoamine oxidase (MAO) in the human body. This is an important baseline study which will allow future studies to assess the potential effect of drugs, foods, or other exposures that inhibit MAO. Drug studies, however, are not a part of this effort. MAO breaks down neurotransmitter amines and vasoactive chemical compounds present in certain fermented foods, drugs, and beverages. If MAO is inhibited, the individual is at risk for dangerous elevations in blood pressure. Therefore, a knowledge of the effect of drugs and other substances on MAO is important. Positron emission tomography (PET) imaging will allow this assessment to be made directly in the human body. MAO exists in two subtypes, MAO A and MAO B, which differ in their selectivity for breaking down different chemical compounds.
We are studying 36 subjects in two years. We will measure MAO A and/or MAO B in each subject. MAO A will be measured using [11C]clorgyline and [11C]clorgyline-D2 (deuterium substituted [11C]clorgyline), and MAO B will be measured using [11C]L-deprenyl and [11C]L-deprenyl-D2 (deuterium substituted [11C]L-deprenyl). Volunteers may participate in either or both of these studies. If they participate in one of the studies they will receive two PET scans and if they participate in both of the studies, they will receive four PET scans.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Brain Dopamine and Reward and Motivation in Controls and Substance Abusers"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2000
This project ended in fiscal year 2006.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 01/21/05
Explanation of IRB approval:
Study inactivated at continuing review 01/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
For Study #1, we will use positron emission tomography (PET) to assess the involvement of dopamine (DA) in motivation and reinforcing behavior in healthy control subjects using food stimulation (n=10), mathematical stimulation (n=20), and video stimulation (n=10) and to compare these responses to neutral stimulation. For Study #2, we will compare responses to reinforcing (behavioral) stimuli and neutral stimuli in cocaine abusers (n=20) and healthy control subjects (n=20). We will compare the responses to drug and non-drug related behavioral reinforcers (stimulation) and compare these responses to neutral stimulation.
For this study, we predict that (1) DA in human subjects will be involved with reward and motivational circuits and (2) cocaine abusers will have decreased activation of reward circuits by naturally rewarding stimuli when compared with controls, but they will have very robust responses to drug related stimuli.
In addition to the above, we will contact obese subjects (n=10) who participated in a comparable study to determine if their obesity status is similar to what it was a few years ago, and if it is, we will ask these subjects to return to BNL to complete the Dutch Eating Behavior Questionnaire. We want to investigate whether obese subjects have different eating behaviors from normal body weight subjects and to correlate their eating behaviors with the PET results obtained from another protocol. The reason for this is that this study has shown that brain DA is involved with the restraint and emotionality components regulating eating behavior in humans and that these two dimensions reflect different neurobiological processes in normal body weight subjects (control subjects). The total number of subjects approved for this study is 90.
All records are confidential and may not be disclosed without the subject's written permission with the exception that funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Perception of Pleasure and Control of Behavior in Drug Addiction: An fMRI Study"
Principal Investigator: Dr. Rita Goldstein, Brookhaven National Laboratory
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 03/23/06
IRB approval number: 20066133
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 32
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The goal of the present research is to evaluate human brain function implicated in the perception of pleasure and control of behavior by simultaneous functional magnetic resonance imaging (fMRI) recordings and behavioral assessment, and by cognitive event related potential (ERP) testing. Specifically, this project will examine whether chronic use of cocaine and/or alcohol changes the pattern of this brain activity in such a way as to increase the uncontrollable use of these drugs. The results of this work will provide information on the brain circuits underlying drug-related behaviors, emotions, and cognitions, which may then open the possibility of timely intervention and prevention of drug addiction. The human brain mapping will be obtained using a 4 Tesla (4T) magnetic resonance imaging (MRI) scanner with presentations of visual and/or auditory stimuli to subjects in the scanner. Electrophysiological (ERP) data will be acquired outside the MRI environment using NeuroScan 64-channel equipment. No radiopharmacueticals, chemicals (drugs), or surgical procedures will be used in this study. The total duration of the fMRI study will be two hours or less. ERP testing requires a further two hours. Subjects will include 25 normal controls, and 50 cocaine abusers or alcoholics a year.
The study is considered to involve minimal risk. No serious ill effects have been reported to date from any site operating with 4T magnetic field strength or ERP testing. Because of the strong magnetic field, however, subjects will be screened for the presence of any surgically implanted metallic devices such a clips, artificial joints, heart valves, and pacemakers. Since the study involves entering a confining space (the magnet), subjects may not be able to participate if they have a history of claustrophobia, or if they experience anxiousness when entering the magnet. The risks due to the magnet are primarily related to the slight possibility of a sensation of dizziness or nausea as subjects move into and out of the magnet, or move their head within the magnet; no risk larger than minimal has been identified with ERP testing. All records are confidential and may not be disclosed without the subject's written permission with the exception that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records. Documented informed consent is obtained from all subjects in a manner compliant with all federal regulations.
"Brain Imaging Studies of Obesity"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 10/15/04
Explanation of IRB approval:
Study inactivated at continuing review 10/05.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The prevalence of obesity is increasing worldwide. The mechanisms leading to the loss of control of food intake are not understood. Dopamine (DA) is one of the neurotransmitters that involve feeding behavior and its pharmacological manipulation has marked effects on food intake. Abnormal dopaminergic activity has been demonstrated in genetically inbred mice for obesity and has been postulated to underlie disorders entailing compulsive behaviors such as overeating. Our prior study showed that striatal DA D2 receptor availability was significantly lower in obese than in control subjects. It has been postulated that subjects who have low dopamine activity are more prone to self-administer food or reinforcing drugs as a way of compensating for the decreased dopaminergic activity. Animal studies indicate a decrease in body weight by dietary restriction increases DA D2 receptor concentration. Bariatric operations include procedures that decrease the volume capacitance of the stomach or establish a partial selective malabsorption are used to induce weight loss. These surgical procedures have been proven to be effective at inducing and maintaining a significant weight loss. The purpose of this study is to investigate if changes in the brain dopamine system of obese individuals revert to normal with surgically assisted weight loss. The study will evaluate 30 obese subjects (body mass index > 40 kg/m2) who are to undergo bariatric surgery and 30 control subjects in the age range 20 to 55 years of age. Obese subjects will be tested prior to and 6 to 12 months after surgery. Each evaluation will entail studies with two tracers, to measure postsynaptic DA sites ([11C]raclopride for dopamine D2 receptors) and to measure regional brain function (18F-fluorodeoxyglucose, for regional glucose metabolism) using positron emission tomography (PET) scans. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"PET Imaging Studies of Brain Dopamine: Changes in Subjects Infected with Human Immunodeficiency Virus (HIV)"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 12/16/04
Explanation of IRB approval:
Study inactivated at continuing review 12/05.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Clinical and laboratory studies indicate human immunodeficiency virus (HIV) infection frequently results in brain dopaminergic dysfunction and dementia. This dementia syndrome is called HIV cognitive motor complex (CMC). The purpose of this study is to investigate changes in the brain dopamine system of subjects infected with HIV and the efficacy of highly active antiretroviral treatment. The study will compare 80 HIV subjects with or without a history of psychostimulant drug use, 20 to 65 years of age who have not yet begun highly active antiretroviral medication, with 20 age matched healthy control subjects. Each evaluation will entail positron emission tomography (PET) studies with two tracers to measure: postsynaptic dopamine (DA) sites ([11C]raclopride for dopamine D2 receptors) and presynaptic DA sites ([11C]cocaine for dopamine transporter). HIV subjects will be asked to repeat testing 6 to 12 months after treatment using the same two tracers. We predict that subjects with HIV dementia have a decrease in DA transporters, which leads to Parkinsonian signs and HIV-CMC. We postulate that these abnormalities are partially compensated with normal or up-regulated DA receptors. We predict that effective highly active antiretroviral treatment will improve dopamine function. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. Any area where the skin anesthetic will be applied may become red and/or irritated. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"PET Studies of Cocaine Abuse: Effects of Expectation"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 04/06/06
IRB approval number: 20066131
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to compare the activation of the brain in response to intravenous methylphenidate (brand name Ritalin), a drug that, like cocaine, also blocks removal of dopamine. Brain activation will be compared when cocaine abusers are expecting to receive the drug versus to when they are not, and to assess if expectation can activate a similar circuit to that activated by the drug in current cocaine abusers under four different conditions: 1) subjects are told they will receive placebo and are given placebo; 2) subjects are told they will receive methylphenidate and are given placebo; 3) subjects are told they will receive methylphenidate and are given methylphenidate; and 4) subjects are told they will receive placebo and are given methylphenidate. We will complete studies in a total of 96 (n=96) subjects: 48 subjects for Study Part 1A and 48 subjects for Study Part 1B. For Study Part 1A, subjects will have four fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, each one on a different day. For Study Part 1B, subjects will have four raclopride PET scans, two of each on two days of study. A magnetic resonance imaging (MRI) scan is also run to assess structural abnormalities, such as atrophy.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high." It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"PET Studies in Attention Deficit Disorder: Role of Dopamine"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2001
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 01/25/06
IRB approval number: 20056074
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this research is to assess if there are changes in the brain of subjects with attention deficit hyperactivity disorder (ADHD). More specifically, we want to assess if there are abnormalities in brain dopamine (DA), which is a chemical that regulates attention and motor activity in the brain. Dopamine is also the chemical that is affected by drugs used in the treatment of ADHD such as Ritalin and Adderall. We will use positron emission tomography (PET) to measure dopamine brain activity in adult subjects with ADHD. We will use [11C]cocaine to measure dopamine transporters (DAT), and we will use [11C]raclopride with and without methylphenidate pretreatment to measure changes in extracellular dopamine. ADHD is a disorder characterized by hyperactivity and attention problems that affects five to ten percent of the general population. Despite the large numbers of people affected by ADHD, very little is known about what causes it. In this study brain DA activity will be measured using an imaging camera called PET to image the molecules involved in the communication of the dopamine signals in the brain (dopamine transporters, dopamine receptors, and dopamine itself). We will complete studies in no more than 50 subjects: 25 with ADHD and 25 normal controls. Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high." It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Blood Brain Barrier Permeability in MS Lesion Development"
Principal Investigator: Dr. William Rooney, Oregon Health and Science University
Project started in: 2001
This project ended in fiscal year 2006.
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Brookhaven National Laboratory
Most recent approval: 02/18/05
Explanation of IRB approval:
Study inactivated at continuing review 02/06.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine if brain blood vessels let contrast agent or water pass through more easily in people with multiple sclerosis (MS) than in people who do not have the disease. This information may help investigators better diagnose and possibly identify brain regions where lesions may soon appear. Twenty five MS subjects and twenty five control subjects will undergo scanning with an research-dedicated magnetic resonance imaging (MRI) instrument. MS subjects and controls will be studied at multiple times. Each subject will receive an injection of an FDA-approved, gadolinium-based contrast agent which will assist the investigators in measuring brain blood vessel properties. The MRI machine creates a strong magnetic field. If subjects have certain metal objects in the body, for example, metal fragments in the eye, non-removable hearing aids, nerve stimulators, or pacemakers, they would not be allowed to enter the magnet area and cannot participate in this study. Subjects may be bothered by feelings of claustrophobia while in the scanner. Because the magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) scanner makes loud "knocking" noises, they are asked to wear earplugs. While the MRI/MRS makes the "knocking" noise, subjects might feel a tingling sensation in their arms or legs, but it is unlikely that this will occur. Subjects may become dizzy or experience a metallic taste in the mouth if they move the head quickly in the magnet. The radio waves produced by the scanner could cause a warm sensation, but this is unlikely. Although the long-term risk of exposure to the MRI/MRS machine is not known, there is no known long-term risk based on the information collected over the past 20 years. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and, on rare occasions, infection. Occasionally the area around the vein may swell. The risks of a gadolinium injection include discomfort and bruising at the site of puncture and, less commonly, the formation of a small blood clot or swelling of the vein and nearby tissue and bleeding from the puncture site. A small number of people have had bad reactions to the gadolinium contrast agent solution. Some of the bad reactions include headache, dizziness, metallic taste in mouth, nausea, and rash or hives. Death has been reported due to severe allergic reactions, but this has been an extremely rare occurrence with an estimated risk of 1 in 500,000. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Brain Dopamine, Reward and Motivation in Obese Subjects With and Without a Binge Eating Disorder"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 01/25/06
IRB approval number: 20056072
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine if dopamine is involved in the response to pleasurable, stressful, or unpleasant food experiences in obese subjects. Twenty obese subjects with a binge eating disorder and 20 obese subjects without a binge eating disorder will be studied. First, they will receive a dose of methylphenidate or a placebo. They will not know which they are receiving. Following the administration of methylphenidate or placebo, they will either see, smell, taste or be exposed to a variety of foods, or see, smell, taste or be exposed to things such as pictures, toys, clothing items or be asked questions that do not result in a strong emotional feeling or response. Following the behavioral intervention, they will undergo a position emission tomography (PET) scan. PET is a type of camera which will take pictures of the subject's brain. Each subject will be asked to return on a separate day to undergo the same procedure, but in reverse order as the first day.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. The effects of inserting needles to draw blood are usually some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated.
A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Imaging of Neuroendocrine Tumors Using PET (COMT)"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 05/25/06
IRB approval number: 20066181
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine whether the radiotracers [18F]Ro41-0960 and [11C]clorgyline can be used with positron emission tomography (PET) to image a neuroendocrine tumor (NET). Five normal subjects and 20 subjects with NET that produce catecholamines (NETC) will have only one injection of [18F]Ro41-0960 with two whole body PET scans; one beginning at 60 minutes after radiotracer injection and the other about four hours after radiotracer injection. Twenty subjects with NET that produce serotonin (NETS) will have only one injection of [11C]clorgyline with only one whole body PET scan about 10 minutes after radiotracer injection. If the tumor(s) can be visualized after examining the data from the first whole body scan in the subjects with NET that produce NETC, it may not be necessary to perform the second whole body scan in some of these subjects. We shall evaluate the feasibility of using [18F]Ro41-0960 and [11C]clorgyline to visualize NETS in human subjects. NETS subjects who show a positive result from their [11C]clorgyline PET scan will be asked to return for two more PET scans: one with [11C]clorgyline and the other with [11C]clorgyline-D. With this knowledge we can begin to devise effective approaches to treat and cure this devastating medical illness.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Heavy Ion Induced Chromosome Damage and Biomedical Countermeasures"
Principal Investigator: Dr. Francis Cucinotta, NASA Johnson Space Center
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: Stony Brook University
Most recent approval: 02/17/06
IRB approval number: 20066086
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to determine the effect of radiation on chromosomes. Blood samples will be drawn from subjects several hours before irradiating these samples at the NASA Space Radiation Laboratory (NSRL) at BNL. Whole blood will be exposed to ions at various doses up to 1.5 Gy. After irradiation, lymphocytes will be stimulated to grow in culture and incubated. Samples will be collected after chromosomes are forced to condense in both the interphase and metaphase stages of the cell cycle. Chromosome damage will be assessed using fluorescence markers for individual chromosomes. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Clinical Correlates of Longitudinal PET Changes in Alzheimer's Disease (AD): A Glucose Challenge Study"
Principal Investigator: Dr. Mony J. de Leon, NYU School of Medicine
Project started in: 2002
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 05/11/06
IRB approval number: 20066130
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to examine the effects of higher than normal levels of glucose (sugar) on cognitive performance (mental activity) and on glucose metabolism in the brain. A specific goal is to try to understand whether abnormal glucose metabolism may underlie the memory loss that occurs in Alzheimer's disease. Brain glucose metabolism will be measured using a positron emission tomography (PET) scan. PET is a type of camera that takes pictures of the subject's brain. Each PET scan will involve the administration of the radiotracer 18-fluorodeoxyglucose (18FDG). A radiotracer is a radioactive chemical that is injected into the bloodstream in very small amounts. Each subject will be scanned twice: once with and once without the administration of glucose. Eight control subjects and eight subjects with early Alzheimer's Disease will be studied and compared.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. There should be no risk associated with the amount or time of glucose infusion. However, if glucose is infused too quickly it can leak through the vein and form a lump in the vein and/or cause a burning sensation. Infusing glucose too quickly could also cause mental confusion and/or loss of consciousness. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Imaging of Brain Metabolic Responses to Food Presentation"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 03/27/06
IRB approval number: 20066132
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The purpose of this study is to compare the effect of behavioral and neutral stimulation on brain glucose metabolism. Brain glucose metabolism will be measured using a positron emission tomography (PET) scan. PET is a type of camera that takes pictures of the subject's brain. Each PET scan will involve the administration of the radiotracer 18-fluorodeoxyglucose (18FDG). A radiotracer is a radioactive chemical that is injected into the bloodstream in very small amounts. Study #1A, Specific Aim 1: We will evaluate brain glucose metabolic activity in 20 normal control subjects under food, neutral, and baseline interventions. We hypothesize that frontal (orbitofrontal cortex), parietal (somatosensory cortex), and hypothalamic metabolism will be significantly increased in food presentation when compared to neutral/baseline (no intervention) conditions. We also hypothesize that parietal (somatosensory cortex) metabolism will be significantly increased in neutral stimulation when compared to baseline condition.
Study #1B, Specific Aim 1: We will evaluate brain glucose metabolic activity in 20 normal control subjects under the food desire, attempted inhibition, and baseline interventions. We hypothesize that metabolism in the superior frontal gyrus and anterior cingulate gyrus will be significantly increased and orbitofrontal metabolism will be decreased in the attempted inhibition when compared to food desire conditions. We hypothesize that parietal (somatosensory cortex), orbitofrontal and insular metabolism will be significantly increased in food desire condition when compared to baseline condition. We also hypothesize the association of emotion (i.e., decreased food desire) with increased metabolic change in anterior cingulate gyrus. Forty control subjects will be studied.
Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Botulinum Toxoid Immunization"
Principal Investigator: Dr. Joseph P. Falco, Brookhaven National Laboratory
Project started in: 2002
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 02/15/06
IRB approval number: 20056059
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
This study's purpose is to prevent Botulism (reaction to toxin) in employees working with Botulinum toxin by administration of Botulinum toxoid. There are three subjects participating in this study. Subjects will be given injections at 0, 2, and at 12 and 24 weeks. The first booster will be given 12 months after the initial series. Subsequent booster injections are given at 1-year intervals.
"Methamphetamine Effects in Brain Dopamine Activity"
Principal Investigator: Dr. Gene-Jack Wang, Brookhaven National Laboratory
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 09/01/06
IRB approval number: 20064835
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
PART 1: We will use positron emission tomography (PET) and the radiotracer [11C]raclopride to assess the test/retest reproducibility for the measures of dopamine changes in five normal controls with PET and raclopride with and without pretreatment of oral methylphenidate at baseline and again within a one-month period.
PART 2: In this part of the study, we will investigate how much damage methamphetamine (METH) does to the human brain and to evaluate whether the brain can recover with detoxification from METH after a drug-free period of about six to nine months. We will use [11C]cocaine to measure dopamine transporter levels and [11C]raclopride to measure dopamine cell function by comparing the binding of [11C]raclopride with and without pretreatment or oral methylphenidate. A magnetic resonance imaging (MRI) scan will be obtained in this part of the study to correct for potential brain deterioration in the subjects, and this will be repeated on the return visit 6 to 9 months later. We want to test over a four-year period 40 METH abusers during early withdrawal (between two weeks and three months of last METH use) and then retest them six to nine months later after a drug-free period. Twenty normal controls will be tested in parallel and 10 of them will be retested 6 to 9 months later.
Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral "high." It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered orally, the likelihood of cardiac stimulation is lower. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals who have a prior history of seizure disorders. Therefore, methylphenidate will not be given to patients with cardiac disease or patients with seizure disorders.
Arterial catheterization has the following rare, but possible, complications: pain during the placement of the catheter, a risk of bleeding at the skin puncture site; the possibility of local infection, and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance injected by venipuncture, there is minor discomfort and a slight possibility of some pain, bleeding and/or a bruise or swelling where the needle was inserted and on rare occasions, infection. Occasionally the area around the vein may swell. Any area where the skin anesthetic will be applied may become red and/or irritated. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. All records are confidential and may not be disclosed without the subject's written permission, except that the Food and Drug Administration (FDA) and/or funding agencies may inspect the records.
"Clinical Correlates of Longitudinal PET Changes in Normal Aging, Mild Cognitive Impairment and Alzheimer's Disease"
Principal Investigator: Dr. Mony J. de Leon, New York University School of Medicine
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: Stony Brook University
Most recent approval: 05/23/06
IRB approval number: 20066198
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 46
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement: