Recruiting

Imaging Biomarkers

Sponsor:

Tammie L. S. Benzinger, MD, PhD

Code:

NCT04134923

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[11C] Pittsburgh Compound-B (PIB)

Study Details

Brief 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).

Conditions

Alzheimer Disease

Study ID

NCT04134923

Start date

Jun 8, 2021

Status verified date

Aug, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

375 participants

Anticipated

Interventions and Outcome Measures

Arms

[11C] Pittsburgh Compound-B (PIB)

Using \[11C\] Pittsburgh Compound-B (PIB) to look for biomarkers in preclinical and symptomatic AD.

Interventions

[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 measure

  • develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kelley Jackson

314-297-7602kelleyj@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Lauren Ash

314-273-6175lash@wustl.edu

More Information

Sponsor

Tammie L. S. Benzinger, MD, PhD

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • Alzheimer's disease
  • neurology
  • radiology
  • Nuclear medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tammie L. S. Benzinger, MD, PhD on 2025-08-07.