Imaging Biomarkers in Preclinical and Symptomatic AD (ACS_PIB_IND)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: [11C] Pittsburgh Compound-B (PIB)

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 Type: Observational
• Enrollment (Estimated): 375

Contacts and Locations

• Study Contact: Name: Kelley Jackson; Phone Number: 314-297-7602; Email: kelleyj@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Lauren Ash; Phone Number: 314-273-6175; Email: lash@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
[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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tammie L. S. Benzinger, MD, PhD
• Investigators: Principal Investigator: Tammie Benzinger, MD, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's disease; neurology; radiology; Nuclear medicine
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Anti-Inflammatory Agents; Corticosterone
• Other Study ID Numbers: 201906028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No