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

NCT05393388 | Active Not Recruiting FDA Drug

• 1 other identifier: 844403
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Uptake of [18F]AV-1451 in the medial temporal lobe

  A quantitative measurement of \[18F\]AV-1451(standardized value uptake ratio - SUVR) within the medial temporal lobe (MTL).from PET/CT

  4 years

• Volume of medial temporal lobe subregion

  A quantitative measurement of volume (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.

  4 years

• Thickness of medial temporal lobe subregion

  A quantitative measurement of thickness (milimeters - mm) of medial temporal lobe (MTL) subregion from a high resolution MRI.

  4 years

Study Arms (1)

PET/CT

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

Drug: [18F]AV-1451

Interventions

[18F]AV-1451 DRUG

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

Also known as: [F-18]T807

PET/CT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes cognitively normal, older adult (\>65 years old) black or African American participants

You may qualify if:

• Males and females African Americans ≥ 65 years of age.
• Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.
• ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the \[18F\]AV-1451 TAU PET scan.
• 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.
• An amyloid PET scan completed or scheduled within 1year of their study \[18F\]AV-1451
• Women must be post-menopausal or surgically sterile.

You may not qualify if:

• 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.
• Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
• Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
• Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.
• Women of child bearing potential

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania - Penn Memory Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• David A Wolk, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: July 6, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)