Enrollment Complete in Study of Non-Invasive Therapy for Alzheimer’s

Cognito Therapeutics has achieved its 670-participant enrollment in the HOPE Study, a pivotal trial evaluating the safety and efficacy of its proprietary therapy, Spectris, in patients with Alzheimer’s disease (AD).

The HOPE Study is the largest ever conducted that is exclusively focused on Alzheimer’s disease patients. Participants will use Cognito’s neuromodulating device daily at home for 12 months. The study is designed as a randomized, double-blind, sham-controlled trial conducted at 70 clinical U.S. sites. The trial is followed by a 12-month open label extension study.

“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,” Cognito Therapeutics CEO Christian Howell stated. “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.”

The Spectris AD system delivers synchronized light and sound sensory stimulation at the 40Hz gamma frequency, shown in the OVERTURE feasibility study to preserve corpus callosum structure in Alzheimer’s disease patients.

The HOPE Study builds upon positive results from Cognito’s earlier OVERTURE study, which demonstrated a 76% reduction in cognitive decline (MMSE), a 77% reduction in functional decline (ADCS-ADL), a significant preservation of white matter, and a 69% reduction in whole brain atrophy over six months (MRI).

The HOPE study will assess the efficacy of Spectris in slowing disease progression versus sham for subjects with mild to moderate AD as measured by a composite of ADCS-ADL and MMSE as the primary endpoint.

“There is an urgent need for safe, effective, and scalable treatments for Alzheimer’s,” Cognito Therapeutics Chief Medical Officer Ralph Kern, M.D., said. “Our technology is non-invasive, has shown strong early signals in functional and structural outcomes, and may be uniquely suited to deliver a home-based therapy that meets the unmet need of Alzheimer’s patients and their care partners.”

The Spectris AD system is investigational and not available for sale.

Cognito Therapeutics is a late clinical-stage medical device company pioneering neuroprotective therapies to address the unmet needs of patients living with CNS disorders. Its lead product, Spectris AD, is an at-home therapeutic device that uses non-invasive, sensory-driven neurostimulation to evoke gamma frequency brain activity. The company’s feasibility studies have shown the potential for Spectris AD to preserve cognition, daily function, and slow brain atrophy in patients diagnosed with mild-to-moderate AD. Cognito is headquartered in Cambridge, Mass.