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Cognito Therapeutics announces positive results from Phase II study in Alzheimer’s disease

Tuesday 09 March 2021

On 9 March, Cognito Therapeutics, a clinical-stage company developing digital therapeutics for neurodegenerative diseases announced results from its Phase II trial investigating neuromodulation therapy for Alzheimer’s disease (AD). This device uses gamma frequency technology as a way to stimulate the brain in a non-invasive way.  The Overture Phase II study is a multi-center, randomised and controlled trial aiming to study the safety, adherence rates and efficacy of an audio-visual stimulation treatment in people with mild to moderate cognitive impairment. 76 participants aged 50 and older received the therapy or the placebo for one hour each day in their home.

Results showed that after six months, participants who received the treatment had a significant 84% slowdown in functional decline compared to the placebo group. In addition, there was a significant 61% reduction in whole brain atrophy as well as in volumetric loss among the group receiving the stimulation treatment. The company is planning to move onto a large-scale pivotal clinical trial of its neuromodulation therapy, which received a Breakthrough Device Designation by the US Food and Drug Administration (FDA) in January 2021.