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NCT Number: NCT03372317

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

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.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Ashley Mensing, BS

CONTACT

[email protected]

212-305-6314

Yaakov Stern, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

18F-MK-6240

Drug

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

Primary outcomes

  1. Total number of individuals with tau present

    Time frame: Up to 5 years

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

  2. Cognition

    Time frame: Up to 5 years

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

  3. Functional imaging (fMRI)

    Time frame: Up to 5 years

    Relation of Tau PET to imaging acquired during task performance

Study contacts

Contact information is provided by the study sponsor or research team.

Reshma Babukutty

CONTACT

[email protected]

212-305-6314

Sponsors and collaborators

Lead sponsor

Yaakov Stern

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Tau Positron Emission Tomography (PET) in Imaging and Cognition

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2017
Registry last updated
Feb 11, 2026

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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