Clinical trial NCT03372317: Tau PET in Imaging and Cognition: Healthy Adults From 55-90
Official title: Tau Positron Emission Tomography (PET) in Imaging and Cognition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Cognitive Impairment
Aging
Keywords: Tau
MK-6240
Cognition
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-12-13
Enrollment: 105
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects, 55-90 years old that previously received an amyloid PET scan

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.

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

Primary outcomes:
measure: Total number of individuals with tau present
timeFrame: Up to 5 years
measure: Cognition
timeFrame: Up to 5 years
measure: Functional imaging (fMRI)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Yaakov Stern, PhD
role: PRINCIPAL_INVESTIGATOR
References: