RecruitingNCT04134923

Imaging Biomarkers in Preclinical and Symptomatic AD

Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)

Sponsor

Tammie L. S. Benzinger, MD, PhD

Enrollment

375 participants

Start Date

Jun 8, 2021

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria7

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

Interventions

DRUG[11C] Pittsburgh Compound-B (PIB)

Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer \[11C\] PIB. Participants will then undergo a \[11C\] PIB PET/CT scan conducted in the Center for Clinical Imaging Research (CCIR) facility.