Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

NCT03706261 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: AAAR89861RF1AG058067-01A1
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The study employs tau positron emission tomography (PET) imaging in a well-characterized multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with cognition, differences in tau pathology across racial/ethnic groups, and the relationship between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also investigates amyloid-dependent tau spreading.

Conditions

Alzheimer Disease

Keywords

Tau; Amyloid; MK-6240; Florbetaben; Racial/Ethnic Minority; Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• Regional SUVR Value for 18F-MK-6240

  Regional standardized uptake value ratio (SUVR) for 18F-MK-6240 will be calculated to investigate associations with measures of memory, olfactory function, and cerebrovascular disease.

  1 day

• Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben

  18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.

  1 day

Study Arms (1)

Offspring Cohort

EXPERIMENTAL

Racially/ethnically diverse subjects with or without a positive family history of Alzheimer's disease (AD) will have one PET scan with 18F-MK-6240 over a 30 to 60-minute scanning period, and one PET scan with 18F-Florbetaben over a 20-minute scanning period.

Drug: 18F-MK-6240; Drug: 18F-Florbetaben

Interventions

18F-MK-6240 DRUG

Administration of 5 mCi of 18F-MK-6240 for tau PET.

Also known as: [18F]MK-6240

Offspring Cohort

18F-Florbetaben DRUG

Administration of 8.1 mCi as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL of 18F-Florbetaben for Aβ PET imaging.

Also known as: [18F]Florbetaben

Offspring Cohort

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 35 - 85 years
• Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking.
• Able to participate in all scheduled evaluations and to complete all required tests and procedures
• Considered likely to comply with the study protocol and to have a high probability of completing the study

You may not qualify if:

• Past or present history of a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease.
• Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
• Unable to lie still for PET scans.
• Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study.
• Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug.
• Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.).
• Inability to have a catheter in your vein for the injection of the radioligand (dye).
• Currently pregnant or breastfeeding.

Sponsors & Collaborators

• Adam Brickman: 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; Pick Disease of the Brain

Interventions

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

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Results Point of Contact

• Title: Adam M. Brickman, PhD
• Organization: Columbia University

amb2139@cumc.columbia.edu

212-342-1348

Study Officials

• Adam M. Brickman, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neuropsychology

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 15, 2018
• Study Start: March 22, 2019
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Locations

US (1)