At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Qualify [18F]MK-6240 Positron Emission Tomography (PET) for Use as a Biomarker of Neurofibrillary Tangle Pathology in Alzheimer's Disease
In Brief
A Phase 1 clinical trial evaluating [18F]MK-6240, ~185 MBq and [18F]MK-6240, ~160 MBq for Alzheimer's Disease and Amnestic Mild Cognitive Impairment. Completed, enrolled 13 participants.
Detailed Summary
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of \[18F\]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to correlate with the severity of cognitive impairment in AD. The objectives of the study include performing the following with respect to \[18F\]MK-6240 administered as a PET imaging agent: 1) assess safety and tolerability; 2) determine radiation safety profile; 3) determine optimal imaging protocol parameters for quantification of brain NFTs in AD; 4) compare tracer binding in brain PET scans from participants with AD, participants with amnestic mild cognitive impairment (MCI) and healthy elderly participants; and 5) evaluate intra-subject test-retest (T-RT) variability of tracer uptake in brain regions of interest.
Study Details
Timeline
Interventions
IV dose of \~185 MBq \[18F\]MK-6240
IV dose of \~160 MBq \[18F\]MK-6240