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

NCT ID: NCT03372317

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

18F-MK-6240

Intervention Type DRUG

Results of the 18F-MK-6240 PET scan will be correlated with other observations.

Interventions

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18F-MK-6240

Results of the 18F-MK-6240 PET scan will be correlated with other observations.

Intervention Type DRUG

Other Intervention Names

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6-[18F]Fluoro-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Yaakov Stern

OTHER

Sponsor Role lead

Responsible Party

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Yaakov Stern

Professor of Neuropsychology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yaakov Stern, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Reshma Babukutty

Role: CONTACT

212-305-6314

Facility Contacts

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Ashley Mensing, BS

Role: primary

212-305-6314

Other Identifiers

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2RF1AG038465-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR6959

Identifier Type: -

Identifier Source: org_study_id

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