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Cognito Therapeutics announced Phase II study results demonstrating that its digital therapeutic, which uses gamma frequency neuromodulation, helped patients with mild-to-moderate Alzheimer's disease (AD) improve memory, cognition and functional abilities, while also reducing whole brain atrophy and volumetric loss. The findings were presented at the Alzheimer's & Parkinson's Diseases (AD/PD) conference.
CEO Brent Vaughan remarked that "with our recent FDA breakthrough device designation, we look forward to expediting the clinical development of what has the promise to be the first disease-modifying digital therapeutic in Alzheimer's disease."
The OVERTURE study evaluated the safety and efficacy of gamma frequency neuromodulation in 76 patients aged 50 years or older with mild-to-moderate AD. Participants were randomised to receive auditory and visual sensory stimulation with Cognito's GammaSense device or placebo one-hour daily at home for six months. During the study period, participants were regularly evaluated for cognitive, functional and biomarker changes. Brain volumetric changes were assessed by structural magnetic resonance imaging.
According to Cognito, the study met its safety and tolerability endpoints, and select secondary endpoints "were significant." Over the six-month period, patients in the treatment group exhibited a significant 84% slowing of functional decline based on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and a significant 83% slowing in memory and cognitive decline as measured by Mini-Mental State Examination (MMSE) scores, compared to placebo.
In addition, Cognito said patients in the treatment group also saw a significant 61% reduction in whole brain atrophy and volumetric loss associated with AD, compared with placebo at six months. Chief medical officer Tom Megerian suggested this particular finding "addresses key aspects of AD aetiology and disease progression," and if these results can be "replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer's research."
Meanwhile, company president Zach Malchano indicated that Cognito is "[advancing] clinical development of our proprietary gamma frequency neuromodulation approach as a standalone therapy or in combination with other therapeutics in development for the treatment of Alzheimer's."
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