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

Aging Clinical Trial

Official title:

Tau Positron Emission Tomography (PET) in Imaging and Cognition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372317
• Other study ID #: AAAR6959
• Secondary ID: 2RF1AG038465-06
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Reshma Babukutty
• Phone: 212-305-6314
• Email: rb2996[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yaakov Stern	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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