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Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

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ClinicalTrials.gov Identifier: NCT03706261
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Adam Brickman, Columbia University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: 18F-MK-6240 Drug: 18F-Florbetaben Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023


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.

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.




Primary Outcome Measures :
  1. Regional SUVR value for 18F-MK-6240 [ Time Frame: 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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 55 - 75 years
  • Are undergoing a structural MRI scan as a part of the Offspring Study
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706261


Contacts
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Contact: Adam M Brickman, Ph.D. 212-342-1348 amb2139@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Adam Brickman, Ph.D.       amb2139@cumc.columbia.edu   
Principal Investigator: Adam Brickman, Ph.D.         
Sponsors and Collaborators
Adam Brickman
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Adam M Brickman, Ph.D. Columbia University

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Responsible Party: Adam Brickman, Associate Professor of Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT03706261     History of Changes
Other Study ID Numbers: AAAR8986
1RF1AG058067-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Analyses are planned to be on the group level. However, we may emphasize cases that are interesting on the individual level.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Brickman, Columbia University:
Tau
Amyloid
MK-6240
Florbetaben
Racial/Ethnic Minority
Alzheimer's disease

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders