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Tau PET in Imaging and Cognition: Healthy Adults From 55-90

Sponsor
Yaakov Stern (Other)
Overall Status
Recruiting
CT.gov ID
NCT03372317
Collaborator
National Institute on Aging (NIA) (NIH)
105
Enrollment
1
Location
66
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then examine the interactions between differential tau burden and performance on cognitive tasks, functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive and behavioral measures. By investigating these relationships, the investigators hope to understand the cognitive and behavioral outcomes of tau deposition found in specific brain regions in cognitively normal/mildly cognitively impaired adults. Furthermore, the study aims to examine how the presence of tau may contribute to the risk of subsequent cognitive decline, neurodegeneration, and dementia.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Many cognitively healthy older adults have, upon post mortem evaluations, been found to have varying amounts of neurofibrillary tangles (tau) and beta-amyloid plaque deposits, which are the hallmark brain pathologies known to be associated with Alzheimer's disease and various other dementias. While some with these pathologies may not clinically express cognitive decline or dementia in their lifetime, human post-mortem studies suggest that increasing neurofibrillary tangle density correlates with neurodegeneration and cognitive impairment.

Imaging tauopathy in-vivo provides an opportunity to examine neurocognitive correlates of differential levels of tauopathy in the brain, allowing to further qualify pre-clinical states of cognitive impairment. The investigators aim to investigate possible protective mechanisms, such as cognitive reserve, that may modulate the relationship between tauopathy and cognitive decline.

Study Design

Study Type:
Observational
Anticipated Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Tau Positron Emission Tomography (PET) in Imaging and Cognition
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Non-demented elders

Participants aged 55-90 that are cognitively normal or have mild cognitive impairment will receive 18F-MK-6240 to identify the presence of tau protein in the brain.

Drug: 18F-MK-6240
Results of the 18F-MK-6240 PET scan will be correlated with other observations.
Other Names:
  • 6-[18F]Fluoro-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total number of individuals with tau present [Up to 5 years]

      Based on the scans, the total number of subjects with identifiable tau in their scans will be measured.

    2. Cognition [Up to 5 years]

      Relation of Tau PET to measures of cognition such as memory and reasoning

    3. Functional imaging (fMRI) [Up to 5 years]

      Relation of Tau PET to imaging acquired during task performance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged 55-90

    • Previously received an amyloid PET scan

    • Residing near Columbia University Medical Center

    • Must be willing and able to participate

    Exclusion Criteria:

    • Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)

    • Pregnancy

    • Lactating Women

    • Current, past, or anticipated exposure to radiation

    • Significant active physical illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Yaakov Stern
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Yaakov Stern, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yaakov Stern, Professor of Neuropsychology, Columbia University
    ClinicalTrials.gov Identifier:
    NCT03372317
    Other Study ID Numbers:
    • AAAR6959
    • 2RF1AG038465-06
    First Posted:
    Dec 13, 2017
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Yaakov Stern, Professor of Neuropsychology, Columbia University
    Tau
    MK-6240
    Cognition
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Feb 11, 2022