USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-93-101-H01

Project Title:

APOE4 in Alzheimer's Disease (see LBL-93-12-75 in 1994 database)

Principle Investigator: Dr. Ananth Acharya

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

Unfunded postdoctoral pilot.

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: September 08, 1995
IRB Approval Number: CPHS 94-12-57

Number of Human Subjects in the Last Reporting Period for this Project: 25
(Reporting periods vary.)

Type of Human Subjects Involvement:

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.

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of existing data that were collected for another purpose or project.

Other use of human subjects:

Genome analysis.

(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 study a statistically observed relationship between the frequency of the E4 allele of the apolipoprotein gene E4 (APOE4) and Alzheimer's disease. Frequency of APOE4 will be correlated with previously collected data from subjects with Alzheimer's disease (AD). The technique that will be used is isoelectric focusing (IEF). Societal benefits include opportunities for future pharmacologic interventions from linking varied phenotypes to one or more genetic abnormalities.

METHODOLOGY

A single 10-cubic centimeter (cc) blood sample will be taken from each patient through the arterial line which is already in place for the positron emission tomography (PET) study. This is in addition to the 125 cc which will be drawn as part of the PET study (see LBNL-88-073-H02, "Longitudinal PET & SPECT Studies of Dementia"). For patients who have completed their PET study, venipuncture will be performed. The sample will be taken to the laboratory of Dr. Ronald Krauss, where IEF will be performed.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

None.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

Risks include: venous catheter (bruising, faintness); arterial catheter (bruising, faintness)