Therapy Areas: Devices
Cerveau Technologies Starts Japanese Phase I Study
18 November 2019 - - The first healthy volunteer was injected and scanned in the Japan Phase I study of [F18]MK-6240, an investigational imaging agent, US-based diagnostics and technology collaboration Cerveau Technologies, Inc. said.
The study received clearance from the Japanese regulatory agency, the Pharmaceutical and Medical Devices Agency and is being conducted at Kobe City Medical Center General Hospital.
The study will include healthy volunteers and patients with Mild Cognitive Impairment and with Alzheimer's Disease, and is designed to confirm the safety and pharmacokinetics profile of [F-18]MK-6240 in Japanese.
MK-6240 is an investigational imaging agent, in Positron Emission Tomography scans to assess the status and progression of neurofibrillary tangles in the brain.
NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer's Disease.
Cerveau Technologies is a collaboration between Enigma Biomedical Group, Inc. and Sinotau Pharmaceutical Group.
Cerveau's vision is to globally develop diagnostics and technology that positively impact patients with neurodegenerative disorders including Alzheimer's Disease.