NCT03071224

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this protocol is to evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.

Detailed description

The overall goal of this protocol is to evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical. * To measure the dynamic uptake and washout of \[18F\]MK-6240 in brain using positron emission tomography (PET) in patients with Alzheimer's disease and healthy volunteers. * To measure blood metabolites of \[18F\]MK-6240 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input. * To obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease and healthy volunteers (Cohort 1). * To acquire safety data following injection of \[18F\]MK-6240. * 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. * To evaluate the correlation between the longitudinal change in tau burden and change in clinical, MRI and CSF biomarker measures in AD subjects and in similarly-aged HV subjects. * To further explore the relationship between tracer metabolism and smoking (Cohort 3).

Conditions

• Alzheimer Disease
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[18F] MNI-946	Subjects will undergo PET imaging using \[18F\]MNI-946, a PET radioligand for imaging tau.
DRUG	[18F]Florbetapir	Subjects with Alzheimer's disease will receive a \[18F\]florbetapir scan to compare distribution of tau in the brain compared to that of \[18F\]MNI-946.

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-06-09
• Completion: 2021-06-09
• First posted: 2017-03-06
• Last updated: 2021-06-14

Locations

1 site across 1 country: United States