- Results from two OVERTURE brain MRI analyses further validates Spectris’™ mechanism of action and demonstrates the impact on corpus callosum structural maintenance in mild-to-moderate Alzheimer’s disease

Cognito Therapeutics, a pioneering neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, today announced new data from its OVERTURE feasibility trial at the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases. The results showed that Spectris™, the company’s non-invasive investigational neuromodulation device, maintains corpus callosum structure and evokes gamma oscillation responses that correlate with baseline brain structure in patients with mild-to-moderate Alzheimer’s disease.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250402055525/en/

Illustration of Cognito Spectris device for the treatment of Alzheimer's disease. Image credit: Cognito Therapeutics

In a comparative MRI analysis, patients treated with Spectris daily for six months showed statistically significant preservation of the corpus callosum, the brain’s largest white matter tract responsible for interhemispheric communication. Compared to matched controls from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), Spectris patients maintained brain volume (+0.58%) while matched ADNI controls showed a decline (-0.91%), a net difference of +1.49% (p<0.004). Subregions of the corpus callosum such as the genu, anterior and posterior body, and splenium, all showed statistically significant treatment differences.

In a second analysis, Cognito evaluated whether 40 Hz sensory-evoked gamma oscillations, the specific neural response induced by Spectris, correlate with brain structure. Using EEG and MRI data from OVERTURE participants, the company found that EEG gamma power and phase-locking were correlated with temporal and occipital lobe volume and cortical thickness in MRI brain studies. Gamma power specifically correlated with temporal lobe volume (R=0.56, p<0.0003) and occipital cortical thickness (R=0.62, p<0.0003). Notably, age had no significant effect on these EEG parameters, suggesting broad applicability across the elderly population.

“These new findings provide strong, complementary evidence that Spectris not only engages an important neurophysiological target, but also maintains structural integrity in the Alzheimer’s brain,” said Christian Howell, Chief Executive Officer, Cognito Therapeutics. “With no observed amyloid-related imaging abnormalities (ARIA) convenient at-home use, and mounting clinical and mechanistic evidence, we believe Spectris is poised to become a transformative therapy for Alzheimer’s disease.”

“Spectris is unique in that we are inducing gamma oscillations, that are otherwise disturbed in Alzheimer’s disease, and demonstrating they have significant downstream effects on the brain’s structural health,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “These results highlight the potential for biomarker-guided treatment and disease modification.”

Spectris™ is currently being evaluated in HOPE, a pivotal, randomized, sham-controlled trial enrolling 670 patients with mild-to-moderate Alzheimer’s disease. The therapy has been granted Breakthrough Device Designation by the U.S. FDA. Topline results from the HOPE study are expected in mid-2026.

Unlike anti-amyloid monoclonal antibodies that require infusions and frequent MRI monitoring, Spectris™ is designed for daily at-home use with zero observed risk of ARIA and >80% adherence in the OVERTURE study. The therapy is expected to be more cost-effective than antibody-based treatments, offering a scalable, potentially safer, and economically viable solution for Alzheimer’s care.

For more information about the HOPE study, visit www.hopestudyforad.com.

About Cognito Therapeutics

Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris™, uses non-invasive auditory and visual neuromodulation to enhance gamma frequency brain activity, with the goal of slowing brain atrophy and functional decline in Alzheimer's disease. Cognito is committed to developing transformative, technology-driven interventions to address unmet needs in the treatment of CNS diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250402055525/en/