Imaging Biomarkers in Preclinical and Symptomatic AD

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: [11C] Pittsburgh Compound-B (PIB)

• Registration Number: NCT04134923
• Lead Sponsor: Tammie L. S. Benzinger, MD, PhD

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).

Study Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Study Start: 2021-06-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States