CAMBRIDGE, Mass.– New findings from Cognito Therapeutics suggest that the company’s investigational neuromodulation device, Spectris™, may help maintain brain structure in patients with mild-to-moderate Alzheimer’s disease. The data, presented at the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, stems from the OVERTURE feasibility trial and provides further validation of Spectris’ mechanism of action.
According to the study, patients who used Spectris daily for six months exhibited significant preservation of the corpus callosum, the brain’s largest white matter tract, which facilitates communication between hemispheres. MRI analysis revealed that Spectris-treated patients maintained brain volume (+0.58%) compared to a decline (-0.91%) in matched controls from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), yielding a net difference of +1.49% (p<0.004). Several key subregions of the corpus callosum also showed statistically significant treatment differences.
Further analysis explored how Spectris-induced 40 Hz sensory-evoked gamma oscillations relate to brain structure. Researchers found that EEG gamma power and phase-locking correlated with temporal and occipital lobe volume and cortical thickness, key indicators of brain health. Specifically, gamma power was associated with temporal lobe volume (R=0.56, p<0.0003) and occipital cortical thickness (R=0.62, p<0.0003), with no significant impact from patient age, suggesting broad applicability across elderly populations.
“These findings provide compelling evidence that Spectris not only engages an important neurophysiological target but also helps maintain structural integrity in the Alzheimer’s brain,” said Christian Howell, CEO of Cognito Therapeutics. “With no observed amyloid-related imaging abnormalities (ARIA), convenient at-home use, and growing clinical validation, Spectris has the potential to become a transformative therapy for Alzheimer’s disease.”
Dr. Ralph Kern, the company’s Chief Medical Officer, emphasized the uniqueness of Spectris’ approach. “Unlike traditional treatments, Spectris directly induces gamma oscillations, which are disrupted in Alzheimer’s disease, and we’re now seeing meaningful downstream effects on brain structure.”
Spectris is currently being tested in the HOPE trial, a pivotal, randomized, sham-controlled study enrolling 670 patients with mild-to-moderate Alzheimer’s. The therapy has received Breakthrough Device Designation from the U.S. Food and Drug Administration, and topline results are anticipated in mid-2026.
Unlike anti-amyloid monoclonal antibodies, which require infusions and frequent MRI monitoring, Spectris is designed for daily at-home use, with over 80% adherence observed in the OVERTURE study. With its non-invasive nature and potential cost-effectiveness, the therapy could offer a scalable and economically viable alternative for Alzheimer’s treatment.
