On March 30th 2023 Cognito Therapeutics announced neuroimaging results evaluating the effects of the company’s non-invasive neuromodulation medical device, which delivers proprietary gamma frequency light and sound stimulation in participants with Alzheimer’s disease (AD). The results were presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, on March 28–April 1, 2023 in Gothenburg, Sweden.
Neuroimaging data was prospectively collected in the OVERTURE clinical trial (NCT03556280) along with safety, tolerability, and efficacy of Cognito Therapeutics’ medical device in participants with Alzheimer’s disease. 76 participants were randomised 2:1 to receive daily, one-hour, EEG-assessed, proprietary non-invasive neuromodulation (active arm, n=46) or sham (placebo arm, n=28) stimulation over a 6-month period. AD brain pathological changes were evaluated by neuroimaging methods, including volumetric MRI and [18]florbetapir PET.
Results
A significant reduction in whole brain volume loss was observed, which correlated with reduced lateral ventricle expansion, in subjects in the active compared to the sham group. The active group also showed a significantly reduced loss in white matter volume, occipital lobe volume and cortical thickness. Volumetric changes showed correlations between brain regions and clinical outcomes, prominently between occipital lobe and activity of daily living (ADCS-ADL). Although neither the active nor the sham arm participants showed a significant difference in amyloid plaque load, Cognito’s proprietary neuromodulation was effective in both amyloid positive and negative subjects, including maintaining cognitive and functional efficacy outcomes.
The results presented at AD/PD 2023 from our Phase 2 OVERTURE clinical trial show that daily at-home use of our medical device decreases brain atrophy in Alzheimer’s patients. Our innovative approach, utilising non-invasive neuromodulation and neuroimaging methods, has yielded impressive results, including a significant reduction in whole brain MRI volume loss and potentially improved clinical outcomes. We are particularly encouraged by the correlations between reduced brain volume loss and clinical outcomes, as well as the impact of our therapy on both amyloid positive and negative patients. These findings indicate a potential breakthrough in Alzheimer’s research and provide hope for the millions of individuals and families affected by this disease. We remain committed to advancing our research and development efforts in bringing our innovative neurotechnology device to patients.
Brent Vaughan, CEO, Cognito Therapeutics.
Cognito Therapeutics is a clinical-stage neurotechnology company developing disease-modifying therapeutic approaches to treat neurodegenerative disorders. Its non-invasive neuromodulation platform was developed by MIT Professors and scientific founders Li-Huei Tsai and Ed Boyden. The Company’s lead therapy is currently in a pivotal study in Alzheimer’s Disease and was awarded FDA Breakthrough Device Designation. Cognito is based in Cambridge, MA. For more information, visit www.cognitotx.com.
