Cognito Therapeutics announced today that it completed enrollment in the HOPE study evaluating its non-invasive Spectris neuromodulation system.
The pivotal study evaluating the safety and efficacy of Spectris in patients with Alzheimer’s disease enrolled 670 participants. Cambridge, Massachusetts–based Cognito says it marks the largest medical device pivotal trial exclusively focused on patients with Alzheimer’s disease.
HOPE, a randomized, double-blind, sham-controlled trial takes place across 70 U.S. clinical sites. Investigators plan a 12-month open-label extension study to follow. Cognito hopes results build on positive outcomes from the OVERTURE study reported last month.
The study evaluates Spectris, a system that delivers proprietary gamma frequency light and sound stimulation. This evokes EEG-confirmed gamma frequency brain oscillations to treat central nervous system (CNS) diseases. It restores brain electrical activity disrupted in Alzheimer’s.
Cognito says HOPE aims to assess Spectris’ efficacy in slowing disease progression.
“Completing enrollment in this landmark trial marks a major step forward in our mission to deliver a better treatment option for people living with neurodegenerative conditions, like Alzheimer’s,” said Christian Howell, CEO, Cognito Therapeutics. “We’re proud to lead one of the largest and most advanced device studies in the history of Alzheimer’s disease, and we’re grateful to the patients, families, and clinicians who are helping us bring a new therapeutic modality to this underserved community.”
