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Clinical Trials/NCT03372317
NCT03372317
Recruiting
Not Applicable

Tau Positron Emission Tomography (PET) in Imaging and Cognition

Yaakov Stern1 site in 1 country105 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
18F-MK-6240
Conditions
Mild Cognitive Impairment
Sponsor
Yaakov Stern
Enrollment
105
Locations
1
Primary Endpoint
Functional imaging (fMRI)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 1, 2027
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yaakov Stern
Responsible Party
Sponsor Investigator
Principal Investigator

Yaakov Stern

Professor of Neuropsychology

Columbia University

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: 18F-MK-6240

Outcomes

Primary Outcomes

Functional imaging (fMRI)

Time Frame: Up to 5 years

Relation of Tau PET to imaging acquired during task performance

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.

Cognition

Time Frame: Up to 5 years

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

Study Sites (1)

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