Roche aims to recruit a diverse population across 17 countries in new phase III study.
Pharma giant Roche and its subsidiary Genentech have announced the start of a new Phase III clinical trial called SKYLINE for their investigational medicine, gantenerumab, a monoclonal anti-amyloid antibody aimed to treat Alzheimer's disease. The goal of the trial is to see if gantenerumab can delay the advancement of Alzheimer's disease in those who have the initial biological indications of the condition, before too much irreparable brain damage is done, according to a statement. To further exchange scientific insights and achieve the trial goals, the Swiss company plans to engage with three institutions, Massachusetts General Hospital, the University of Southern California Alzheimer’s Therapeutic Research Institute and the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute.
The study will enroll 1,200 adults between the ages of 60 and 80 who are amyloid positive but show no evidence of cognitive impairment. The main goal of the study is to see change from the time treatment began to year four in the Preclinical Alzheimer’s Cognitive Composite-5 score, a measure to check changes in cognitive function. It is also being evaluated in a primary prevention trial in people who are genetically predisposed to developing the disease before amyloid plaques form in the brain. The two studies, Graduate 1 and 2, comprise more than 2,000 patients with the appearance of initial symptoms or early Alzheimer's across more than 30 countries. Results from these trials are expected in Q4 2022.