USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory


Project Identification:

Project Identifier: LBNL-88-073-H02

Project Title:

Longitudinal SPECT & PET Studies of Dementia (see LBL-93-6-65 in 1994 database)

Principle Investigator: Dr. William J. Jagust

Project started in: 1988


Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-DOE Federal: National Institutes of Health (NIH)
Amount: $120,000 (Est.)


Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2

Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 24

IRB Review:
Type of Review: Full Board
Most Recent Approval: June 12, 1995
IRB Approval Number: CPHS 95-6-117

Number of Human Subjects in the Last Reporting Period for this Project: 24
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

OBJECTIVES

Utilize magnetic resonance imaging (MRI) and positron emission tomography (PET) on patients with Alzheimer's disease, Parkinson's disease, and multi-infarct dementia to understand the longitudinal effects of these conditions on cerebral metabolism. Develop new radiotracers which will provide a measure of the presynaptic degeneration in these cases; correlate the presynaptic degeneration with behavioral changes. The new tracer will also be used to investigate serotonergic degeneration in these diseases. Societal benefits may include a greater understanding of dementing illnesses.

METHODOLOGY

Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm and another will be placed in an artery or vein of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial (or other venous) catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects then watch a video display terminal on which words are presented. A delayed word presentation is used to determine the duration of subjects' memory. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last 60 to 90 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans totaling approximately 30 minutes.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Fluorine-18 Fluorodeoxyglucose

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

PET scan risk includes: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness); radiation (equivalent to back x-ray). If an arterial catheter is to be placed, lidocaine is used to provide local anesthesia before placing the catheter.

MRI scan risk includes: discomfort associated with lying still in an enclosed space.


Protocol/Subproject # 2
Protocol/Subproject Identifier: RMP 47

IRB Review:
Type of Review: Full Board
Most Recent Approval: March 23, 1995
IRB Approval Number: CPHS 95-2-119

Number of Human Subjects in the Last Reporting Period for this Project: 3
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

OBJECTIVES

To clarify the mechanisms through which subcortical lacunar infarction may lead to cognitive impairment and dementia using magnetic resonance imaging (MRI) to quantify features of lacunae, high resolution positron emission tomography (PET) to measure cerebral metabolic rates for glucose (CMRglc) and neuropsychological tests. Benefits to the subjects may include the diagnostic utility of these imaging techniques, as well as the neuropsychological testing. Societal benefits may include a better understanding of dementia and cerebrovascular disease.

METHODOLOGY

Subjects are offered water before their study begins. A catheter will be placed in a vein in one arm and another will be placed in an artery or vein of the hand on the other arm. The venous catheter will be used to inject the radiotracer and the arterial (or other venous) catheter will be used to collect blood samples to verify the rate at which the radiotracer is cleared from the blood. After a half-hour uptake phase, subjects are asked to empty their bladder to keep the radiation exposure to the bladder as low as possible. Subjects are then positioned in the PET scanner, where the technician provides blankets and padding in order to make them as comfortable as possible. Subjects may not move during the scan, which may last approximately 90 minutes. Subsequently, the subjects may be placed in an MRI scanner for 2 scans totaling less than 30 minutes. Subjects will also undergo neuropsychological testing at the University of California at Davis, Northern California Alzheimer's Disease Center.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Fluorine-18 Fluorodeoxyglucose

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

PET scan risk includes: venous catheter (bruising, faintness); arterial catheter (bruising, pain, faintness); radiation (equivalent to back x-ray). If an arterial catheter is to be placed, lidocaine is used to provide local anesthesia before placing the catheter.

MRI scan risk includes: discomfort associated with lying still in an enclosed space.


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