NCT04134923 · Tammie L. S. Benzinger, MD, PhD
Imaging Biomarkers in Preclinical and Symptomatic AD
(ACS_PIB_IND)
What this study is about
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).
View original scientific description
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).
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.
Primary outcome measures
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD
Time frame: 5 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St Louis, Missouri
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2025 · Source of record for eligibility and locations