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

NCT03372317 | Recruiting FDA Drug

• 2 other identifiers: AAAR69592RF1AG038465-06
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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

Keywords

Tau; MK-6240; Cognition

Outcome Measures

Primary Outcomes (3)

• Total number of individuals with tau present

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

  Up to 5 years

• Cognition

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

  Up to 5 years

• Functional imaging (fMRI)

  Relation of Tau PET to imaging acquired during task performance

  Up to 5 years

Study Arms (1)

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

Interventions

18F-MK-6240 DRUG

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

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

Non-demented elders

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects, 55-90 years old that previously received an amyloid PET scan

You may qualify if:

• Aged 55-90
• Previously received an amyloid PET scan
• Residing near Columbia University Medical Center
• Must be willing and able to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Yaakov Stern: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and cells will be retained

MeSH Terms

Conditions

Cognitive Dysfunction; Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yaakov Stern, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reshma Babukutty

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neuropsychology

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: June 1, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Study data will be available within 1 year
• Access Criteria: We will be sharing de-identified data with a consortium that is aggregating studies that have employed tau PET tracers

Locations

US (1)