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

Tau Positron Emission Tomography (PET) in Imaging and Cognition

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Mild Cognitive Impairment
• Intervention / Treatment: Drug: 18F-MK-6240

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 Type: Observational
• Enrollment (Estimated): 105

Contacts and Locations

• Study Contact: Name: Reshma Babukutty; Phone Number: 212-305-6314; Email: rb2996@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Principal Investigator: Yaakov Stern, PhD
      • Contact: Ashley Mensing, BS; Phone Number: 212-305-6314; Email: ao2454@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yaakov Stern
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Yaakov Stern, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cognition; Tau; MK-6240
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AAAR6959; 2RF1AG038465-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data could be shared based on NIH regulations
• IPD Sharing Time Frame: Study data will be available within 1 year
• IPD Sharing Access Criteria: We will be sharing de-identified data with a consortium that is aggregating studies that have employed tau PET tracers

Drug and device information, study documents

• 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