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Active, Not Recruiting

NCT Number: NCT05393388

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania - Penn Memory Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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)*

Treatment and study plan

[18F]AV-1451

Drug

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

Other names: [F-18]T807

Primary outcomes

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

    Time frame: 4 years

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

  2. Volume of medial temporal lobe subregion

    Time frame: 4 years

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

  3. Thickness of medial temporal lobe subregion

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Acronym: ABCD2-TAU

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 26, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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