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Cognito Therapeutics on Monday presented updated study findings at the Alzheimer's Association International Conference (AAIC) bolstering its claim that its gamma frequency neuromodulation therapy has disease-modifying potential in patients with Alzheimer's disease (AD). Chief scientific officer Mihaly Hajos remarked "we are excited to present this…data for the first time, showing that our digital therapeutic reduces loss in brain atrophy, a key driver of disease progression in AD."
The Phase II OVERTURE study involved 74 patients with clinical presentation ranging from prodromal to mild cognitive impairment and mild-to-moderate AD who were randomised to receive daily, one-hour gamma sensory stimulation with the company's GammaSense system or sham stimulation over a six-month period. Anatomical and structural magnetic resonance imaging (MRI) data were collected at baseline, at three months and six months using 1.5 Tesla MRI.
Patients who received the gamma frequency neuromodulation achieved a 65% reduction in whole brain volume loss compared to placebo, representing a further improvement from the 61% reduction reported in an earlier analysis this year (see Wider View: "Unexpected" findings to provide critical learnings for Cognito's Alzheimer's DTx]. Researchers found no significant differences in volumes of lateral ventricles or hippocampi between groups.
Cognito also highlighted the "strong association between disrupted sleep and the development and progression of AD," noting that its gamma frequency neuromodulation had a beneficial effect in that regard as well. The company said "nighttime active durations" in the treatment group were significantly decreased in the second three months, compared to the first three months, whereas the opposite change was observed in the placebo group.
The results demonstrate that "our unique neurophysiological medicine approach can affect disease modification by improving memory, cognition and functional symptoms while also reducing brain atrophy," said CEO Brent Vaughan. He added "the improvements we have now reported in nighttime sleep…provide further support for our mechanism of disease modification in this patient population."
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