Roche and three leading research institutions combine expertise on new Alzheimer ’s prevention trial

Phase III trial will evaluategantenerumab in cognitively unimpaired people with the earliest biologicalsigns ofAlzheimer ' sdiseaseRoche and research institutions have jointly leveraged their scientific expertise on Alzheimer ’s disease to design the new studyBasel, 3 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced a new Phase III Alzheimer ’s disease prevention trial (SKYLINE, NCT05256134) with gantenerumab, an investigational anti-amyloid antibody that is administered subcutaneously. Roche intends to enter into a collaboration agreement with Banner Alzheimer’s Institute’s Alzheimer’s Prevention Initiative, Massachusetts Gener al Hospital, and the University of Southern California Alzheimer’s Therapeutic Research Institute to further exchange scientific insights and advance the trial goals.SKYLINE, a secondary prevention trial, aims to evaluate the potential of gantenerumab to slow disease progression in people with the earliest biological signs of Alzheimer ’s disease, before too much permanent neurological damage is done. The double-blind, placebo-controlled trial will enrol 1,200 participants 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 cogni...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news