The Cambridge, Massachusetts-based company’s Spectris system could provide disease-modifying therapy for treating Alzheimer’s disease. Its non-invasive neuromodulation device delivers proprietary gamma frequency light and sound stimulation. This evokes EEG-confirmed gamma frequency brain oscillations to treat central nervous system (CNS) diseases.
OVERTURE II, a separate, 12-month study followed the six-month OVERTURE 1 randomized clinical trial. It enrolled 83% of Overture I participants and looked at extended Spectris treatment over 18 months. The study employed a delayed-start analysis to evaluate the potential of Spectris as a disease-modifying therapy.
Cognito reported maintained statistically significant separation of activities of daily living over the 12 months of OVERTURE II. Patients who received sham treatment in OVERTURE 1 who switched to active device treatment in OVERTURE II demonstrated a similar rate of decline of activities of daily living. Whole brain volume also proved similar compared to continued active treatment. The company said delayed treatment recipients failed to catch up to the early treatment group.
These results suggest that combined Spectris outcomes fall in line with published criteria for disease modification. Cognito said the results support early treatment as well. Additionally, the company saw no serious treatment-related adverse events in OVERTURE II. It reported high device adherence (80%), similar to OVERTURE I.
“Clinical studies to date with Spectris have demonstrated high levels of adherence among patients while also showing the potential of Spectris as a disease-modifying therapy,” said Dr. Ralph Kern, chief medical officer of Cognito Therapeutics. “This innovative therapy has the potential to be seamlessly integrated as a home-based treatment into the lives of patients and caregivers.”
