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 : August 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: 18F-MK-6240 Drug: 18F-Florbetaben||Phase 1|
|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|
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.
Administration of 5 mCi of 18F-MK-6240 for tau PET.
Other Name: [18F]MK-6240
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
- 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.
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
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Adam M Brickman, Ph.D.||Columbia University|