Roche and three leading research institutions combine expertise on new SKYLINE Alzheimer’s prevention trial of gantenerumab.

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 enroll 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 cognitive function.

Roche has adopted several strategies to address some of the challenges associated with running clinical trials in an Alzheimer’s disease prevention setting. This includes optional blood-based biomarker pre-screening, providing study participants the choice of dosing either every week or every two weeks and the flexibility of administration at home. Roche is also committed to enabling the recruitment of a diverse population for the study across 17 countries globally. The design of SKYLINE will be presented at the AD/PD congress in Barcelona on March 18, 2022.

The SKYLINE secondary prevention trial will continue to expand the breadth of data being generated by the gantenerumab clinical programme in Alzheimer’s disease. The investigational medicine 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, and in people with early Alzheimer’s Disease. Results from GRADUATE 1 and 2, two Phase III trials investigating the safety and efficacy of gantenerumab in people with early Alzheimer’s disease, are expected in Q4 2022.