Imaging Biomarkers in Preclinical and Symptomatic AD

NCT ID: NCT04134923

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 375 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2029-10-31

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).

Detailed Description

This study will use a radioactive tracer called [11C]-Pittsburgh Compound B (11C]PIB), which is a tracer that binds to beta amyloid protein in the brain. This compound is considered investigational, which means that it has not been approved by the United States Food and Drug Administration (FDA).

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

[11C] Pittsburgh Compound-B (PIB)

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

[11C] Pittsburgh Compound-B (PIB)

Intervention Type: 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.

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tammie L. S. Benzinger, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Tammie L. S. Benzinger, MD, PhD

Professor of Radiology, Neuroradiology Section Professor of Neurological Surgery Director, Knight Alzheimer Research Imaging Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tammie Benzinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelley Jackson

Role: CONTACT

kelleyj@wustl.edu

314-297-7602

Facility Contacts

Lauren Ash

Role: primary

lash@wustl.edu

314-273-6175

Other Identifiers

201906028

Identifier Type: -

Identifier Source: org_study_id