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Recruiting NCT03372317

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

Observational Mild Cognitive Impairment Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-MK-6240.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Aging. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Tau Positron Emission Tomography (PET) in Imaging and Cognition

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Columbia University Medical Center — New York

Identifiers

NCT: NCT03372317 · AAAR6959 · 2RF1AG038465-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗