Observational Study of Imaging Biomarkers in Alzheimer's Disease

This research study is looking at adults whose parents may or may not have Alzheimer's disease. The goal is to understand the brain changes that happen before Alzheimer's symptoms appear. Researchers will use a special imaging scan called a PET/CT scan after you receive a small, safe injection of a radioactive tracer called [11C] Pittsburgh Compound-B (PIB). This tracer helps them see amyloid deposits (protein clumps) in the brain, which are thought to be related to Alzheimer's disease. The study aims to create a timeline of these brain changes over five years. You can join if you are 18 or older and are already participating in the Knight Alzheimer's Disease Research Center at Washington University.

Study design
This is an observational study, meaning researchers will watch and collect information without giving a specific treatment. It plans to include about 375 participants.
What's involved
You would receive a single intravenous injection of [11C] Pittsburgh Compound-B (PIB) and then undergo a PET/CT scan.
Compensation
Not stated in the trial record.
Follow-up
The study aims to measure changes over 5 years to develop an integrated timeline.

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NCT04134923

Imaging Biomarkers in Preclinical and Symptomatic AD

Recruiting
Not specifiedAges 18+Observational
Tammie L. S. Benzinger, MD, PhD
~375 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:[11C] Pittsburgh Compound-B (PIB)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD
Measured over 5 years
Alzheimer Disease
1 sites across 1 states
Missouri1
  • Tammie Benzinger, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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
  • develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD5 years

    the annual rate of CDR progression will accelerate due to the aging of the ACS cohort., and estimate that among \~375 ACS participants who either remain CDR 0 currently and will continue to be clinically assessed or will be the new future enrollees, a total of 45 individuals will progress to CDR\>0 by the end of next funding cycle.