USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-95-255B

Project Title:

11-C-L-Deprenyl-D2 and 18-FDG for Study of Neurodegenerative Diseases

Principle Investigator: Dr. Joanna S. Fowler

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

No subjects were studied this year.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 01, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

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

• Use of bodily materials collected from subjects specifically for this 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])

This study will examine the use of 11-C-L-Deprenyl-D2 as a tracer for the understanding of the basic cellular biochemistry, physiology and pharmacology of neurodegenerative diseases like Parkinson's and Alzheimer's or brain injury such as brain tumors, epilepsy or head trauma. We will compare this with 18-Fluorodeoxyglucose (18-FDG) which generally provides an index of decreased neuronal activity (brain function). This is a basic study of cellular changes accompanying the neurodegenerative process. Subjects will include 12 normal subjects and 23 subjects with either Alzheimer's, epilepsy, brain tumor, Parkinson's or head trauma, all of whom will be studied with 5 millicuries (mCi) of 18-FDG and 15 mCi or less of 11-C-L-Deprenyl-D2. The subjects have a short-lived positron emitter tracer administered and are subsequently scanned with positron emission tomography (PET). 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 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.