On 3 March, the biotechnology company Roche has announced the launch of a new Phase III Alzheimer’s disease (AD) prevention trial with gantenerumab, an investigational anti-amyloid antibody. Roche, the Banner Alzheimer’s Institute’s Alzheimer’s Prevention Initiative, the Massachusetts General Hospital, and the University of Southern California Alzheimer’s Therapeutic Research Institute have jointly leveraged their scientific expertise to design the new study. This SKYLINE trial will evaluate gantenerumab in cognitively unimpaired people with the earliest biological signs of AD. The double-blind and placebo-controlled trial will enrol 1,200 participants, in US and Europe, aged 60 – 80 years who are amyloid positive confirmed by assessing cerebrospinal fluid (CSF) or positron emission tomography (PET), and who show no signs of cognitive impairment. The primary endpoint is change from baseline to Year 4 in the Preclinical Alzheimer’s Cognitive Composite-5 score – an endpoint designed to measure subtle changes in cognitive function.
https://www.roche.com/investors/updates/inv-update-2022-03-03
