CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today the publication of the OVERTURE study results in Frontiers in Neurology. The paper titled "Safety, Tolerability and Efficacy Estimate of Evoked Gamma Oscillation in Mild to Moderate Alzheimer’s Disease," highlights the effects of Spectris, Cognito’s proprietary disease-modifying therapy designed to preserve brain structure and function by evoking gamma frequency oscillations for patients with Alzheimer’s disease (AD).
The OVERTURE clinical trial was a randomized, double-blind, sham-controlled clinical trial conducted over a six-month period at 5 US clinical trial sites, involving participants with mild to moderate AD. Participants were randomly assigned 2:1 to receive self-administered daily, one-hour Spectris therapy designed to evoke EEG-verified gamma oscillations or sham treatment. 76 participants were randomized and shown by EEG to exhibit a baseline response to Spectris therapy, 74 received treatment, and 53 completed all study assessments.
The study found that patients on Spectris treatment reported no serious treatment-limiting adverse events (AEs), including ARIA (amyloid-related imaging abnormalities). MRI scans did not show ARIA in any study participant. The study also demonstrated concordant preservation of brain structure and function among participants receiving the treatment. Device adherence in the active and sham treated groups was approximately 85%. Study blinding was confirmed in participants, caregivers, and raters.
Study efficacy results observed include:
- 77% slowing in functional decline, as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) total score, as compared to the sham group.
- 78% slowing in ADCS-ADL instrumental score decline and an 81% slowing in ADCS-ADL basic score decline in the treated, each as compared to the sham group.
- 76% reduction in memory and cognitive decline, as measured by the Mini-Mental State Exam (MMSE), as compared to the sham group.
- 69% reduction of brain atrophy, as measured by whole brain volume via MRI in the treated, as compared to the sham group.
“Publication of OVERTURE clinical trial results is an important step in our commitment to develop our technology-based therapeutic intervention in Alzheimer’s disease,” said Ralph Kern, M.D., MHSc, Chief Medical Officer of Cognito Therapeutics. “We continue to successfully enroll participants in the HOPE pivotal trial that we believe will generate key clinical data to support regulatory review. We remain dedicated to our mission of developing innovative technology-based therapeutic interventions to improve the lives of individuals affected by Alzheimer's disease.”
“These findings underscore our unwavering commitment to pioneering technology-based therapeutic interventions for neurodegenerative diseases,” said Brent Vaughan, CEO, Cognito Therapeutics. “The outcomes of the OVERTURE trial demonstrate the potential of Spectris, our lead product, in preserving brain structure and function while significantly slowing functional decline and reducing cognitive loss. This publication reinforces our commitment to advancing the field of Alzheimer's research and bringing hope to individuals and families affected by this devastating disease.”
About Cognito Therapeutics
Cognito Therapeutics is a late clinical-stage neurotechnology company dedicated to the development of transformative disease-modifying therapies for neurodegenerative diseases. Cognito’s proprietary approach targets dysregulated network activity in the brain and has shown meaningful outcomes in Alzheimer’s patients. Cognito’s lead product, Spectris, employs a proprietary non-invasive method designed to evoke increased gamma frequency brain activity using auditory and visual neuromodulation to slow the rate of brain atrophy and loss of brain function. Cognito’s mission is to develop a new class of technology-based therapeutic interventions to transform the lives of patients with neurodegenerative diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com.
