Alzheimer's Disease Research Center (ADRC) PET Component Study

NCT07758660 | Enrolling By Invitation Phase 2 FDA Drug

• 2 other identifiers: ACYY0282P30AG066462
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to further engage and characterize Alzheimer's Disease Research Center (ADRC) participants through additional research opportunities, particularly PET imaging. Amyloid and Tau PET imaging will be collected in 24 participants per year, for a total of 120 participants over five years. All participants will be followed longitudinally, including through potential transitions from normal aging to mild cognitive impairment (MCI) and Alzheimer's disease and related dementias (ADRD).

Conditions

Alzheimer Disease; Mild Cognitive Impairment (MCI); Dementia

Outcome Measures

Primary Outcomes (2)

• 18F-FBB Standardized Uptake Value Ratio

  The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-FBB PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).

  Up to 12 months

• 18F-MK6240 Standardized Uptake Value Ratio

  The standardized uptake value ratio is the concentration of radioactivity measured from the 18F-MK6240 PET scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region).

  Up to 12 months

Study Arms (2)

Cognitive impairment

EXPERIMENTAL

Participants with Alzheimer's disease and related disorders, including but not limited to: Frontotemporal dementia, Lewy Body dementia, Creutzfeldt-Jakob disease, other dementias, and subjective or objective features of mild cognitive change.

Drug: 18F-MK6240; Drug: 18F-Florbetaben (FBB)

No cognitive impairment

ACTIVE COMPARATOR

Healthy elderly controls and nonpatient volunteers with subjective or objective features of normal aging.

Drug: 18F-MK6240; Drug: 18F-Florbetaben (FBB)

Interventions

18F-MK6240 DRUG

MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.

Also known as: [18F-MK6240]

Cognitive impairment; No cognitive impairment

18F-Florbetaben (FBB) DRUG

Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. Florbetaben measures amyloid in the brain.

Also known as: [18F] Florbetaben

Cognitive impairment; No cognitive impairment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the Alzheimer's Disease Resource Center (ADRC)
• With or without memory problems or impairment
• Able to participate in all scheduled evaluations and to complete all required tests and procedures in either English or Spanish.
• In the opinion of the PI, the participant must be considered likely to comply with the study protocol and to have a high probability of completing the study.

You may not qualify if:

• Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.)
• Pregnant and/or breastfeeding
• In the opinion of the PI, the subject has been determined unlikely to complete all procedures.

Sponsors & Collaborators

• Patrick Lao: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Patrick J Lao, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences (in Neurology and in the Gertrude H. Sergievsky Center)

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2033
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Up to two weeks after review and approval of the request.
• Access Criteria: Investigator qualifications and previous work will be reviewed by the PI. Subsequent email correspondence will relay the technical criteria needed for access.

Locations

US (1)