Recruiting

Observational Study

Sponsor:

Yaakov Stern

Code:

NCT03372317

Conditions

Mild Cognitive Impairment

Aging

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

18F-MK-6240

Study Details

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.

Conditions

Mild Cognitive Impairment

Aging

Study ID

NCT03372317

Start date

Jun 1, 2018

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

105 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

18F-MK-6240

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

Primary outcome measure

  • Total number of individuals with tau present [ Time Frame: Up to 5 years ]
  • Cognition [ Time Frame: Up to 5 years ]
  • Functional imaging (fMRI) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Reshma Babukutty

212-305-6314rb2996@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Ashley Mensing, BS

212-305-6314ao2454@cumc.columbia.edu

Principal Investigator:

Yaakov Stern, PhD

More Information

Sponsor

Yaakov Stern

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Tau
  • MK-6240
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yaakov Stern on 2026-02-11.