Imaging Biomarkers in Preclinical and Symptomatic AD

NCT04134923 | Recruiting FDA Drug

• 1 other identifier: 201906028
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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

Keywords

Alzheimer's disease; neurology; radiology; Nuclear medicine

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 years

Study Arms (1)

[11C] Pittsburgh Compound-B (PIB)

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

Drug: [11C] Pittsburgh Compound-B (PIB)

Interventions

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

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.

[11C] Pittsburgh Compound-B (PIB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female, any race;
• Age ≥ 18 years;
• Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tammie L. S. Benzinger, MD, PhD: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelley Jackson

CONTACT

314-297-7602; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology, Neuroradiology Section Professor of Neurological Surgery Director, Knight Alzheimer Research Imaging Program

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: June 8, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)