Trial of Gantenerumab in Presymptomatic Amyloid-Beta Positive Alzheimer Disease Announced

A new phase 3 clinical trial (NCT05256134) of gantenerumab (Roche; Basel, Switzerland) for Alzheimer disease (AD) has been announced. This study will be conducted in partnership with the Banner Alzheimer’s Institute’s Alzheimer’s Prevention Initiative, Massachusetts General Hospital, and the University of Southern California Alzheimer’s Therapeutic Research Institute. 

The double-blind placebo-controlled SKYLINE trial is planned for enrollment of 1,200 participants, age 60 to 80, who are amyloid β (Aβ) positive and without cognitive impairment. Presence of Aβ will be assessed with either cerebrospinal fluid (CSF) analysis or amyloid-positron emission tomography (PET).

Change on the Preclinical Alzheimer's Cognitive Composite-5 score will be measured from baseline to year 4. Use of this scale is designed to measure subtle changes in cognitive function over the study period.  

“As populations continue to age, AD is a looming global health crisis,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development, Roche. “The possibility to detect this disease at scale more effectively and to intervene even earlier could potentially improve the lives of millions of people and those who care for them. We are proud to collaborate with key experts in the field and the broader AD community on this study, and we look forward to sharing our learnings in the future.”

Gantenerumab is an investigational antibody designed to bind to aggregated forms of Aβ and remove Aβ plaques from the brain.