Imaging Biomarkers in Preclinical and Symptomatic AD

Alzheimer Disease Clinical Trial

— ACS_PIB_IND  

Official title:

Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134923
• Other study ID #: 201906028
• Status: Recruiting
• Start date: June 8, 2021
• Est. completion date: October 2029

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: Kelley Jackson
• Phone: 314-297-7602
• Email: kelleyj[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: October 2029
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Tammie L. S. Benzinger, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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