Imaging Biomarkers in Preclinical and Symptomatic AD

Purpose

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).

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
[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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Lauren Ash
314-273-6175
lash@wustl.edu

More Details

NCT ID
NCT04134923
Status
Recruiting
Sponsor
Tammie L. S. Benzinger, MD, PhD

Study Contact

Kelley Jackson
314-297-7602
kelleyj@wustl.edu

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).