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

NCT ID: NCT05393388

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2027-05-31

Brief Summary

We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.

Conditions

Cognitive Decline; Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PET/CT

PET.CT using the radiotracer \[18F\]AV-1451

[18F]AV-1451

Intervention Type: DRUG

\[18F\]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.

Interventions

[18F]AV-1451

\[18F\]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.

Intervention Type: DRUG

Other Intervention Names

[F-18]T807

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David A Wolk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania - Penn Memory Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

844403

Identifier Type: -

Identifier Source: org_study_id