Overview

Imaging Biomarkers in Preclinical and Symptomatic AD

Status:
Recruiting
Trial end date:
2029-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to evaluate adult children of parents with and without Alzheimer's disease which represent an ideal population for investigating the biological changes that precede the clinical onset of AD. The investigators will be imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT). This study will use a radioactive tracer called [11C]-Pittsburgh Compound B (11C]PIB), which is a tracer that binds to beta amyloid protein in the brain. This compound is considered investigational, which means that it has not been approved by the United States Food and Drug Administration (FDA).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tammie L. S. Benzinger, MD, PhD
Treatments:
Corticosterone
Criteria
Inclusion Criteria:

- Male or female, any race;

- Age ≥ 18 years;

- Active participants currently enrolled in the Knight Alzheimer's Disease Research
Center (ADRC) at Washington University.

Exclusion Criteria:

- Hypersensitivity to [11C] PIB or any of its excipients;

- Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie
still for extended periods) that make it unsafe for the individual to participate;

- Severe claustrophobia;

- Women who are pregnant or breast-feeding will be excluded from PIB PET participation;

- Has any condition that, in the opinion of the Sponsor-Investigator or designee could
increase risk to the subject, limit the subject's ability to tolerate the research
procedures, or interfere with collection of the data;

- Currently participating in any clinical trial which involves an active study
medication or placebo within the past 30 days before scanning and up to 2-weeks past
the imaging visit.

- Current or recent (within 12 months prior to screening) participation in research
studies involving radioactive agents such that the total research-related radiation
dose to the participant in any given year would exceed the limits set forth in the
U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1