CAMBRIDGE, Mass.– Cognito Therapeutics has completed enrollment in its pivotal HOPE Study, a major clinical trial evaluating the company’s experimental Alzheimer’s therapy, Spectris™ AD. A total of 670 participants have been enrolled, making it the largest U.S. medical device trial focused solely on Alzheimer’s disease to date.
The Spectris device delivers daily, at-home light and sound stimulation at a specific brain frequency (40Hz) intended to slow cognitive and functional decline in people with mild to moderate Alzheimer’s. The HOPE study will follow participants over a 12-month period in a randomized, double-blind, sham-controlled design across 70 clinical sites, followed by a year-long open-label extension.
“This is an important step in developing a new treatment option for patients and caregivers affected by Alzheimer’s,” said Christian Howell, CEO of Cognito Therapeutics. “We’re thankful to the patients, families, and research teams who made this milestone possible.”
The trial builds on earlier data from the company’s OVERTURE study, which suggested the Spectris device may slow cognitive and functional deterioration and reduce brain atrophy. The HOPE study will evaluate changes in cognitive function and daily living abilities using standard Alzheimer’s assessments (MMSE and ADCS-ADL) as primary endpoints.
Cognito’s Chief Medical Officer, Dr. Ralph Kern, said the non-invasive, home-based approach may offer a practical option for treating neurodegenerative conditions. “We’re focused on developing a therapy that’s not just effective, but also accessible,” he said.
The Spectris system remains investigational and is not yet approved for commercial use.
