The company designed its non-invasive Spectris device to deliver proprietary gamma frequency light and sound stimulation. This evokes EEG-confirmed gamma frequency brain oscillations to treat central nervous system (CNS) diseases.
Results from OVERTURE showed that Spectris maintained callosum structure and evokes gamma oscillation responses that correlate with baseline brain structure in patients with mild-to-moderate Alzheimer’s disease.
The comparative MRI analysis saw patients treated with Spectris daily for six months. They showed statistically significant preservation of the corpus callosum — the brain’s largest white matter tract responsible for interhemispheric communication. Investigators compared Spectris to matched controls from the Alzheimer’s Disease Neuroimaging Initiative (ADNI). Cognito said it delivered maintained brain volume (+0.58%) vs a decline (-0.91%) in ADNI.
A second analysis evaluated whether 40 Hz sensory-evoked gamma oscillations correlate with the brain structure. This neural response, induced by Spectris, proved to correlate with temporal and occipital lobe volume and cortical thickness in MRI brain studies. Notably, age had no significant effect on EEG parameters, suggesting broad applicability across the elderly population.
Chief Medical Officer Dr. Ralph Kern says the results highlight the potential for biomarker-guided treatment and disease modification.
“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, Cognito CEO. “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.”
Cognito also has the HOPE trial underway, evaluating Spectris in 670 patients with mild-to-moderate Alzheimer’s. It expects topline results in mid-2026.
