Last reviewed · How we verify
Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease Compared to Healthy Volunteers
The overall goal of this protocol is to evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.
Details
| Lead sponsor | Invicro |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2016-06 |
| Completion | 2021-06-09 |
Conditions
- Alzheimer Disease
- Healthy Volunteers
Interventions
- [18F] MNI-946
- [18F]Florbetapir
Primary outcomes
- To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects. — 1 year
Tracer uptake will be evaluated in regions of interest for analysis of regional \[18F\]MK-6240 binding/uptake and expressed in SUV by using established methods for normalization for 12 AD and 3 HV subjects in Cohort 1, 8 AD and 2 HV subjects in Cohort 2, and 3 AD and 3 HV subjects in Cohort 3. Target regions of interest in the standard volume of interest (VOI) template, will be used for tracer uptake quantitation of potentially increased binding to tau pathology will correspond in particular to the cortical regions of the brain. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MK-6240. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-946.
Countries
United States