USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-94-258

Project Title:

Studies of Brain Aging

Principle Investigator: Dr. Nora D. Volkow

Project started in: 1994

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:

DOE: Office of Health and Environmental Research (OHER)

Amount: $377,000 (Est.)

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: August 02, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 13
(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])

Dopamine is a neurotransmitter which is involved in movement and in cognition. The nerve cells producing dopamine are especially vulnerable and are progressively lost in the normal aging human brain. It has been postulated that some of the motor impairment and cognitive changes that occur in the elderly are associated with the loss in dopaminergic neurons. The purpose of this study is to investigate age-related changes in brain dopamine activity and neuronal loss and its consequences on brain function.

The study will use normal subjects in the age range of 20-95 who will be studied with 4 tracers. In this study we will measure 4 parameters: dopamine nerve terminals, dopamine receptors, brain function and MAO B (neuron loss is accompanied by the proliferation of glial cells which are rich in monoamine oxidase B or MAO B). The tracers are d-threo-[11C]- methylphenidate, [11C]-Raclopride, [18F]-fluoro deoxyglucose and [11C]L-Deprenyl-D2. We will study 120 normal subjects, including approximately 10 males and 10 females per decade of age. Subjects will be recruited from Brookhaven National Laboratory employees, from newspaper ads and by word of mouth. Each subject will be studied with 4 tracers. In parallel, a complete neurological evaluation is performed in all subjects to determine the cognitive and motor consequences of age-related degeneration of the dopamine system. The studies will be carried out within 6 weeks. However, when possible, the four tracer studies will be completed in two days to minimize the number of catheterizations. 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 a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can only be obtained 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 a 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.