Evaluating brain imaging in adults with a family history of Alzheimer's disease
Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)
This study is testing brain scans to see if they can find early signs of Alzheimer's disease in adults who have a parent with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 375 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04134923 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the biological changes that occur before the clinical onset of Alzheimer's disease (AD) by imaging the brains of adult children of parents with and without AD. Participants will undergo brain imaging using a radioactive tracer called [11C] Pittsburgh Compound B, which binds to beta amyloid protein associated with Alzheimer's. The study focuses on detecting amyloid deposits in the brain, which may provide insights into the early stages of dementia. The research is being conducted at the Knight Alzheimer's Disease Research Center at Washington University.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a family history of Alzheimer's disease who are enrolled in the Knight Alzheimer's Disease Research Center.
Not a fit: Patients with hypersensitivity to [11C] PIB, severe claustrophobia, or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and understanding of Alzheimer's disease, potentially leading to better prevention strategies.
How similar studies have performed: Other studies using imaging biomarkers for Alzheimer's disease have shown promise, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tammie Benzinger, MD, PhD — Washington University School of Medicine
- Study coordinator: Kelley Jackson
- Email: kelleyj@wustl.edu
- Phone: 314-297-7602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.