[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
Status:
Completed
Trial end date:
2016-12-27
Target enrollment:
Participant gender:
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.