Tau PET in Imaging and Cognition: Healthy Adults From 55-90 | NCT03372317

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

NCT03372317

Sponsor

Yaakov Stern

Status

Recruiting

Last Update Posted

Feb 11, 2026Actual

Enrollment

105Estimated

Phase

Not provided

Conditions

Mild Cognitive Impairment
Aging

Interventions

18F-MK-6240

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2RF1AG038465-06	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Dec 8, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 11, 2026Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-MK-6240	Drug	Results of the 18F-MK-6240 PET scan will be correlated with other observations.	Non-demented elders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Cognition	Relation of Tau PET to measures of cognition such as memory and reasoning	Up to 5 years
Functional imaging (fMRI)	Relation of Tau PET to imaging acquired during task performance	Up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects, 55-90 years old that previously received an amyloid PET scan

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reshma Babukutty	Contact	212-305-6314		rb2996@cumc.columbia.edu

Overall Officials

Name	Affiliation	Role
Yaakov Stern, PhD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center	Recruiting	New York	New York	10032	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data could be shared based on NIH regulations

Types

Not provided

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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D020774	Pick Disease of the Brain

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D057180	Frontotemporal Dementia

Browse Leaves

Not provided

Browse Branches

Not provided