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

Recruiting

• Conditions: Aging; Mild Cognitive Impairment
• Interventions: Drug: 18F-MK-6240

• Registration Number: NCT03372317
• Lead Sponsor: Yaakov Stern

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.

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 Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Study Start: 2018-06-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2027-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-demented elders	18F-MK-6240	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.

Primary Outcome Measures

Name	Time	Method
Functional imaging (fMRI)	Up to 5 years	Relation of Tau PET to imaging acquired during task performance
Total number of individuals with tau present	Up to 5 years	Based on the scans, the total number of subjects with identifiable tau in their scans will be measured.
Cognition	Up to 5 years	Relation of Tau PET to measures of cognition such as memory and reasoning

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States