Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-TAU)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Cognitive Decline
• Intervention / Treatment: Drug: [18F]AV-1451

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania - Penn Memory Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)*

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PET/CT; PET.CT using the radiotracer [18F]AV-1451	Drug: [18F]AV-1451; [18F]AV-1451 has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.; Other Names: [F-18]T807

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: David A Wolk, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Subjects
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
• Other Study ID Numbers: 844403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No