Trial Outcomes & Findings for Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults (NCT NCT03706261)

NCT ID: NCT03706261

Last Updated: 2025-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 145 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2025-08-01

Participant Flow

Participant milestones

Measure	All Participants 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.
Overall Study STARTED	145
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults

Baseline characteristics by cohort

Measure	All Participants n=142 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	48 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	71 Participants n=5 Participants
Region of Enrollment United States	142 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 115 participants had complete PET scans with this tracer

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.

Outcome measures

Measure	All Participants n=115 Participants 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.
Regional SUVR Value for 18F-MK-6240	1.27 SUVR Standard Deviation 0.23

PRIMARY outcome

Timeframe: 1 day

Population: 126 participants had complete PET scans with this tracer

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

Outcome measures

Measure	All Participants n=126 Participants 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.
Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben	12 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=142 participants at risk 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.
General disorders Headache	13.4% 19/142 • 1 day for each scan, within 24 months of each other

Additional Information

Adam M. Brickman, PhD

Columbia University

Phone: 212-342-1348

Email: amb2139@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place