Amyloid Deposition in Healthy Aging: 18F-AV-45-A14: Clinical Evaluation of Florbetapir F18 (18F-AV-45)

Study ID
STU 072010-219

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • Other Non-Affiliated Sites
  • UT Southwestern-Other

Contact
Jacqueline Gauer
972-883-3243
jacqueline.gauer@utsouthwestern.edu

Principal Investigator
Denise Park

Summary

Study Design: To address the gaps in our understanding of the distinction between normal and pathological brain aging, we propose to add β-amyloid imaging via PET scan to our ongoing, large-scale neuroimaging and behavioral study (The Dallas Lifespan Brain Study). The Dallas Lifespan Brain Study systematically investigates changes in neural activation patterns, brain structure, neurovascular health, and cognitive performance across the entire adult lifespan (aged 20-89). This study (funded by a MERIT award from the NIA to Denise Park) has previously been approved by the UTSW review board (IRB# #072010-112). We will additionally for this study obtain a 10 minute PET scan from a subsample of these individuals. We propose to scan up to 500 participants from ages 30-90 that were recruited from the DLBS (IRB# #072010-112).

Follow-Up Procedure: Two and a half to 4.5 years after their original testing procedures, participants who completed their initial testing will be invited back for 2nd testing in the study (follow-up). To do this, they must also agree to participate in Time 2 testing in the greater Dallas Lifespan Brain Study (IRB #STU-072010-112). A letter will be sent to participants as their follow-up testing time approaches, informing them that the researchers will soon be contacting them (see attached letter). The researchers will call participants to invite them to repeat the study procedures.

Qualifying returning participants will then follow the procedures as outlined below.
Study Procedures:
a) Screening: Participants will be taken from the Dallas Lifespan Brain Study, who have been screened following the approved protocol IRB# #072010-112. Additionally, participants will be seen by a physician at the Alzheimer[Right Quote]s Disease Center at UTSW or the PET Center at UTSW to determine their safety for the PET procedure. Participants for this study who are women of childbearing potential will additionally be screened with a urine pregnancy test which will be administered both at the visit with the physician and at the PET facility before scanning.
b) MMSE: Participants who have not completed the MMSE questionnaire in the last 30 days, may be asked to complete the questionnaire for the purposes of this research study.
c) ADAS-Cog: Participants who did not complete ADAS-Cog during testing for Study STU-0720120-112 may be asked to complete the task during testing for this study. (Administration and Scoring Manual for the Alzheimer[Right Quote]s Disease Assessment Scale. 1994 Revised Edition, Richard C. Mohs, Ph.D. Copyright 1994 by The Mount Sinai School of Medicine)

Procedures and Evaluations during the Research: This study may haveup to 3 visits over the course of up to 2 months (these visits may be combined or certain procedures may occur on different days, depending on the participant[Right Quote]s schedule). During the first visit, participants will sign the Consent Form, and HIPAA Authorization, and subjects may be asked to complete the MMSE questionnaire. The second visit will include the screening visit with a Neurologist. On the day of the third visit, we will conduct a brain imaging scan using a PET scanner. A needle will be inserted into an antecubital vein and 10 mCi of 18F-AV-45, will be injected. Approximately 50 minutes following the injection of 18F-AV-45 subjects will be placed in the PET scanner for a 10 minute brain scan. Following the imaging session they will have a short break of approximately 20 mi

Participant Eligibility

Criteria for Inclusion of Initial Subjects: Participants must be adults aged 30-89 years old. Participants must be included for testing in Study STU-072010-112. At least 20% of participants will be men and at least 15% will be minorities. A high school education or equivalent or higher is required. Participants must be fluent English speakers. In addition to these criteria from the larger project (IRB #072010-112), subjects must additionally demonstrate that they are not currently pregnant if they are women of child-bearing potential. Also women of child-bearing potential must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Florbetapir F 18 Injection.

Criteria for Inclusion of Follow-up Participants
- Returning for Time 2 testing in Study STU-072010-112
- 30 years old or older