Roche announces collaboration for phase 3 Alzheimer’s prevention trial

In a company release, Roche announced a collaboration on a new phase 3 Alzheimer’s disease prevention trial, which will test an investigational subcutaneous anti-amyloid antibody.

The pharmaceutical company will partner with Banner Alzheimer’s Institute’s Alzheimer’s Prevention Initiative, Massachusetts General Hospital and the University of Southern California Alzheimer’s Therapeutic Research Institute for SKYLINE, a secondary prevention trial, which seeks to evaluate the potential of gantenerumab to slow disease progression in people presenting with the earliest biological signs of AD.

The double-blind, placebo-controlled trial is expected to include 1,200 participants, aged 60 to 80 years, who are amyloid positive (confirmed through either cerebrospinal fluid or positron emission tomography) and show no signs of cognitive impairment.

“My colleagues, collaborators and I are pleased about the chance to continue working with Roche, helping to inform the study design, endpoints, recruitment options and promising blood-based biomarker tests used in this important prevention trial,” Eric M. Reiman, MD, a leader of the Alzheimer’s Prevention Initiative and principal study investigator, said in the release. “We are eager to help find and support the widespread, appropriate and affordable use of prevention therapies for people facing Alzheimer’s disease as soon as possible.”

Gantenerumab also is being evaluated in a primary prevention trial examining people who are genetically predisposed to developing AD before amyloid plaques form in the brain, as well as in people with early AD. Results from GRADUATE 1 and 2, phase 3 trials investigating the safety and efficacy of gantenerumab in people with early AD, are expected by the fourth quarter of 2022.

The design of SKYLINE will be presented March 18 at the AD/PD 2022 in Barcelona.