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

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05393388
Collaborator
Pennsylvania Department of Health (Other)
160
Enrollment
1
Location
1
Arm
59.7
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a cross-sectional study using the radiotracer 18F-Flortaucipir to determine the relationship of tau pathology to both cross-sectional and longitudinal clinical and biomarker data of ABCD2 cohort participants who are Cognitively Normal. All subjects will already be part of the longitudinal cohort study, known as the "ABCD2" cohort, of the PMC/ADC. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET/CT scan imaging with 18F-Flortaucipir.This is a cross-sectional study using the radiotracer 18F-Flortaucipir to determine the relationship of tau pathology to both cross-sectional and longitudinal clinical and biomarker data of ABCD2 cohort participants who are Cognitively Normal. All subjects will already be part of the longitudinal cohort study, known as the "ABCD2" cohort, of the PMC/ADC. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET/CT scan imaging with 18F-Flortaucipir.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: PET/CT

PET.CT using the radiotracer 18F-Flortaucipir

Drug: (18F)Flortaucipir
(18F)Flortaucipir has been developed as a positron emitting radiopharmaceutical for in vivo imaging of tau protein aggregates.
Other Names:
  • [F-18]T807
  • [F-18]AV-1451

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Uptake of F18-Flortaucipir in the medial temporal lobe [4 years]

      A quantitative measurement of F18-Flortaucipir (standardized value uptake ratio - SUVR) within the medial temporal lobe (MTL).from PET/CT

    2. Volume of medial temporal lobe subregion [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 [4 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 180 days prior to the 18F-Flortaucipir TAU PET scan.

    4. A brain MRI must be performed within 180 days prior to their study 18F-Flortaucipir 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 180 days of their study 18F-Flortaucipir scan date.

    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)*

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania - Penn Memory Center Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania
    • Pennsylvania Department of Health

    Investigators

    • Principal Investigator: David A Wolk, MD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT05393388
    Other Study ID Numbers:
    • 844403
    First Posted:
    May 26, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Pennsylvania
    Healthy Subjects
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction

    Study Results

    No Results Posted as of May 26, 2022