CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
[11C]MK-6884drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02621606
NCT02621606Phase 1Completed
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A Three-Part Trial to Qualify [11C]MK-6884 Positron Emission Tomography for Use as a Biomarker for Regional M4 PAM Receptor Density Quantification in the Human Brain

Merck Sharp & Dohme LLC·interventional·Posted Dec 3, 2015·Updated Sep 13, 2022

In Brief

A Phase 1 clinical trial evaluating [11C]MK-6884 for Alzheimer's Disease. Completed, enrolled 20 participants.

Detailed Summary

The purpose of this open-label, 3-part study is to investigate the safety and efficacy of \[11C\]MK-6884 as a positron emission tomography (PET) imaging agent for quantifying muscarinic 4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of interest. The study will enroll healthy participants (Parts 1 and 2) and participants with Alzheimer's Disease (AD) (Part 3). The primary efficacy hypothesis is that the average intra-subject test-retest (T-RT) variability of tracer uptake in brain regions of interest is ≤20%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 3, 2015
Enrollment StartJan 8, 2016
Primary CompletionDec 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.6 years ago

Interventions

[11C]MK-6884drug

IV bolus dose of \~370 MBq \[11C\]MK-6884