Phase 1
N=145
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03706261 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Regional SUVR Value for 18F-MK-6240 — 1.27 SUVR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 18F-MK-6240 (Drug); 18F-Florbetaben (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Adam Brickman
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regional SUVR Value for 18F-MK-6240 |
1.27 | — |
| PRIMARY Number of Participants With Amyloid Positivity (Aβ+) for 18F-Florbetaben |
12 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03706261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.