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

Early Phase 1

Completed

• Conditions: Alzheimer Disease; Healthy Volunteers
• Interventions: Drug: [18F] MNI-946; Drug: [18F]Florbetapir

• Registration Number: NCT03071224
• Lead Sponsor: Invicro

Brief 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).

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Status Verified: 2019-09
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-09
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]MNI-946	[18F] MNI-946	To evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.
[18F]MNI-946	[18F]Florbetapir	To evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Invicro; 🇺🇸 New Haven, Connecticut, United States