Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: 18F-MK-6240; Drug: 18F-Florbetaben

Detailed Description

Deposition of hyperphosphorylated tau protein is observed in several neurodegenerative diseases including Alzheimer's Disease (AD), progressive supranuclear palsy, corticobasal degeneration, chronic traumatic encephalopathy, and frontotemporal lobar degeneration. Tau is a microtubular protein and its native function is to provide structural support to neurons. Paired helical filaments composed of dysfunctional tau protein are found in several neurodegenerative diseases. In AD, the clinical progression of dementia has been shown to correlate with the amount and topographical spread of tau throughout the brain. Therefore, detecting and quantifying tau aggregate load in brain would have diagnostic and prognostic potential in clinical management of several neurological diseases. As disease modifying drugs that target tau are being developed, there is a critical need for a reliable method of detecting tau aggregates to confirm pathology in patients entering clinical trials.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Offspring Cohort; 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; Administration of 5 mCi of 18F-MK-6240 for tau PET.; Other Names: [18F]MK-6240; Drug: 18F-Florbetaben; 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.; Other Names: [18F]Florbetaben

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years
Amyloid Positivity (Aβ+) for 18F-Florbetaben	18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.	Up to 5 years

Collaborators and Investigators

• Sponsor: Adam Brickman
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Adam M. Brickman, Ph.D., Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Tau; Amyloid; MK-6240; Florbetaben; Racial/Ethnic Minority
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AAAR8986; 1RF1AG058067-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Analyses are planned to be on the group level. However, we may emphasize cases that are interesting on the individual level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No