Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706261
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2018
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Adam Brickman, Columbia University

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE March 22, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Official Title  ICMJE Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: 18F-MK-6240
    Administration of 5 mCi of 18F-MK-6240 for tau PET.
    Other Name: [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 Name: [18F]Florbetaben
Study Arms  ICMJE 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.
Interventions:
  • Drug: 18F-MK-6240
  • Drug: 18F-Florbetaben
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706261
Other Study ID Numbers  ICMJE AAAR8986
1RF1AG058067-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Adam Brickman, Columbia University
Study Sponsor  ICMJE Adam Brickman
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Adam M Brickman, Ph.D. Columbia University
PRS Account Columbia University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP