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

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ClinicalTrials.gov Identifier: NCT03372317
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yaakov Stern, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment
Mild Cognitive Impairment Aging 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 Design
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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Tau Positron Emission Tomography (PET) in Imaging and Cognition
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 6-[18F]Fluoro-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Cognition [ Time Frame: Up to 5 years ]
    Relation of Tau PET to measures of cognition such as memory and reasoning

  3. Functional imaging (fMRI) [ Time Frame: Up to 5 years ]
    Relation of Tau PET to imaging acquired during task performance


Biospecimen Retention:   Samples With DNA
Plasma, serum and cells will be retained

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects, 55-90 years old that previously received an amyloid PET scan
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372317


Contacts
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Contact: Reshma Babukutty 212-305-6314 rb2996@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Ashley Mensing, BS    212-305-6314    ao2454@cumc.columbia.edu   
Principal Investigator: Yaakov Stern, PhD         
Sponsors and Collaborators
Yaakov Stern
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Yaakov Stern, PhD Columbia University
More Information
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Responsible Party: Yaakov Stern, Professor of Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT03372317    
Other Study ID Numbers: AAAR6959
2RF1AG038465-06 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data could be shared based on NIH regulations
Time Frame: Study data will be available within 1 year
Access Criteria: We will be sharing de-identified data with a consortium that is aggregating studies that have employed tau PET tracers

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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
Keywords provided by Yaakov Stern, Columbia University:
Tau
MK-6240
Cognition
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders