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OpenTrials
Completed

NCT Number: NCT03706261

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-MK-6240

Drug

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

Other names: [18F]MK-6240

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.

Other names: [18F]Florbetaben

Primary outcomes

  1. Regional SUVR Value for 18F-MK-6240

    Time frame: 1 day

    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.

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

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Adam Brickman

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2018
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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