USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-94-255

Project Title:

11-C-L-Deprenyl-D2 for MAO B Mapping

Principle Investigator: Dr. Joanna S. Fowler

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: $154,000 (Est.)

Non-DOE Federal: National Institute of Neurological Disorders and Stroke (NINDS)

Amount: $50,000 (Est.)
Comments:

NS 15380

Total Funding: $204,000

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: January 04, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 17
(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.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in 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])

Monoamine oxidase B (MAO B) is a brain enzyme which increases with normal aging, in neurodegenerative disease, and in brain injury. It is also a therapeutic target for drugs to treat Parkinson's disease and depression. These research studies will be aimed at understanding the association between the loss of neurons and changes in MAO B and ultimately to develop a marker which will allow us to track neuronal loss. These studies will be conducted with 11-C-L-Deprenyl-D2, a tracer which labels brain MAO B. No more than 30 subjects will be studied in a year. Subjects will receive up to 4 injections of 11-C-L-Deprenyl-D2 (a total of 30 millicuries (mCi) or less). Initial studies will be carried out on 6-10 subjects and will compare 11-C-L-Deprenyl-D2 and 11-C-L-Deprenyl. The subjects have the 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 is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.