Tau PET imaging in older adults to study cognitive decline

Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study

This study is testing how Tau PET scans can help us understand cognitive decline in older African American adults who are healthy but may be at risk for Alzheimer's Disease.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: University of Pennsylvania (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05393388 on ClinicalTrials.gov

What this trial studies

This observational study involves conducting Tau PET scans on cognitively normal older adults who are part of the Aging Brain Cohort Dedicated to Diversity Study at the University of Pennsylvania. Participants will undergo a one-day PET imaging session, with annual follow-ups as part of the larger ABCD2 study. The aim is to gain insights into the mechanisms of age-related cognitive decline and preclinical Alzheimer's Disease. The study focuses on African American individuals aged 65 and older, ensuring a diverse representation in cognitive research.

Who should consider this trial

Good fit: Ideal candidates are African American males and females aged 65 and older with normal cognitive function.

Not a fit: Patients with significant medical or psychiatric conditions that could affect their safety or participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cognitive decline and Alzheimer's Disease, potentially leading to better diagnostic and therapeutic strategies.

How similar studies have performed: Other studies using Tau PET imaging have shown promise in understanding Alzheimer's Disease, suggesting that this approach may yield valuable insights.

Eligibility criteria

Inclusion Criteria:

1. Males and females African Americans ≥ 65 years of age.
2. Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.
3. ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the \[18F\]AV-1451 TAU PET scan.
4. A brain MRI must be performed within 1 year prior to their study \[18F\]AV-1451 TAU PET scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
5. An amyloid PET scan completed or scheduled within 1year of their study \[18F\]AV-1451
6. Women must be post-menopausal or surgically sterile.

Exclusion Criteria:

1. Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, including major depression and prior head trauma.
2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
4. Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.
5. Women of child bearing potential

   * The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)\*

Where this trial is running

Philadelphia, Pennsylvania

• Hospital of the University of Pennsylvania - Penn Memory Center — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: David A Wolk, MD — University of Pennsylvania
• Study coordinator: David A Wolk, MD

Conditions Cognitive Decline; Alzheimer Disease; Healthy Subjects