Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: 18F-MK-6240; Drug: 18F-Florbetaben

• Registration Number: NCT03706261
• Lead Sponsor: Adam Brickman

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.

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 Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2019-03-22
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Offspring Cohort	18F-MK-6240	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.
Offspring Cohort	18F-Florbetaben	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.

Primary Outcome Measures

Name	Time	Method
Regional SUVR value for 18F-MK-6240	Up to 5 years	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.
Amyloid Positivity (Aβ+) for 18F-Florbetaben	Up to 5 years	18F-Florbetaben will be calculated to investigate the potential moderation of amyloid on the associations with tau.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States