USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-91-073-H01

Project Title:

Alcohol and Memory: A PET Study (see LBL-93-6-64 in 1994 database)

Principle Investigator: Dr. William J. Jagust

Project started in: 1991

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: $100,000 (Est.)
Comments:

Grant Number AA-09042

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Protocol/Subproject # 1
Protocol/Subproject Identifier: RMP 29

IRB Review:
Type of Review: Full Board
Most Recent Approval: June 21, 1995
IRB Approval Number: CPHS 95-6-111

Number of Human Subjects in the Last Reporting Period for this Project: 18
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

• For diagnostic research.

Chemical Substances:

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

• For diagnostic research.

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or project.

(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 evaluate the efficacy of the Positron Emission Tomography (PET)-fluorodeoxyglucose (FDG-18) modality in combination with neuropsychological techniques to assess cerebral function abnormalities in subjects with Alcohol Dementia (AlcD) and Korsakoff's syndrome (KS). The current trial is aimed at defining brain regions which show impaired function in these subjects.

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 60 to 120 minutes. Subsequently, the subjects may be placed in a magnetic resonance imaging (MRI) scanner for 2 scans.

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, blood clot [1%]); 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.