Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
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|ClinicalTrials.gov Identifier: NCT03706261|
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2018
Last Update Posted : October 12, 2022
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|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.
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|Ages Eligible for Study:||35 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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.
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 Irving Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Adam M. Brickman, Ph.D.||Columbia University|
|Responsible Party:||Adam Brickman, Associate Professor of Neuropsychology, Columbia University|
|Other Study ID Numbers:||
1RF1AG058067-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||October 15, 2018 Key Record Dates|
|Last Update Posted:||October 12, 2022|
|Last Verified:||October 2022|
|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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
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