• HOPE is evaluating Cognito’s investigative non-invasive neuroprotective therapy to better preserve cognition and function in patients with Alzheimer’s.
• The study is the largest ever medical device pivotal study focused on patients with Alzheimer’s disease.

Cognito Therapeutics, a clinical-stage medical device company pioneering non-invasive neuroprotection against neurodegenerative diseases, today announced it has achieved its target of enrolling 670 participants in the HOPE Study, a pivotal study evaluating the safety and efficacy of its proprietary therapy Spectris™, in patients with Alzheimer’s disease (AD).

The HOPE Study (NCT05637801) is the largest medical device pivotal trial ever conducted that is exclusively focused on patients with Alzheimer’s disease. Patients will use Cognito’s neuromodulating device at home each day for 12 months. The study is designed as a randomized, double-blind, sham-controlled trial conducted at 70 clinical sites across the United States. 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,” 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.”

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 (NCT03556280), which demonstrated:

• 76% reduction in cognitive decline (MMSE)
• 77% reduction in functional decline (ADCS-ADL)
• Significant preservation of white matter and 69% reduction in whole brain atrophy over 6 months (MRI)

The objective of the HOPE study is to 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,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “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.

About Cognito Therapeutics

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, MA. For more information, visit www.cognitotx.com and follow @cognitotx.

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