Cognito Therapeutics has announced promising results from a post hoc analysis of its OVERTURE feasibility trial, demonstrating that its investigational Spectris AD therapy can significantly slow the progression of Alzheimer's disease. The findings, published in Alzheimer's & Dementia: Translational Research and Clinical Interventions, represent a potential breakthrough in non-invasive neuromodulation for neurodegenerative diseases.
Novel Physics-Based Approach to Alzheimer's Treatment
Spectris AD utilizes non-invasive neuromodulation through synchronized light and sound stimulation at a gamma frequency of 40Hz to restore brain electrical activity that becomes disrupted in Alzheimer's disease. The therapy is designed for convenient daily use at home and has received Breakthrough Device Designation from the U.S. Food and Drug Administration.
"Our brains are electrical systems, and Alzheimer's disrupts the rhythms that govern memory, cognition, and our ability to function," said Christian Howell, CEO of Cognito Therapeutics. "Spectris AD represents a new class of therapy, one based in physics, that restores these natural neural oscillations without relying on a chemistry-based pharmacologic therapy."
Significant Clinical Benefits Demonstrated
The OVERTURE study enrolled 76 participants with mild-to-moderate Alzheimer's disease and included a six-month randomized, controlled phase followed by a 12-month open-label extension. The post hoc analysis revealed substantial "time saved" across key measures of disease progression.
During the controlled phase, daily one-hour treatments with Spectris AD were associated with:
- 4.83 months of preserved ability to perform daily activities
- 4.56 months of delayed cognitive decline
- 4.09 months of delayed whole-brain atrophy
The benefits became even more pronounced over the full 12-month study period. Patients originally assigned to Spectris AD who continued treatment in the open-label extension took significantly longer to progress to the same levels of decline experienced by the sham group in six months. Specifically, these patients showed 10 months of preservation in MMSE scores, 9 months in ADCS-ADL measures, and 7.5 months in whole brain atrophy metrics.
Strong Safety Profile and Patient Adherence
The therapy demonstrated a favorable safety profile with strong adherence rates exceeding 80% and no observed risk of ARIA (amyloid-related imaging abnormalities), a concerning side effect associated with some antibody-based Alzheimer's treatments currently on the market.
"Spectris AD is a physics-based therapy designed to evoke key biological effects that may help delay the progression of Alzheimer's disease," said Ralph Kern, M.D., MHSc, Chief Medical Officer at Cognito Therapeutics. "By directly targeting disrupted neural oscillations through non-invasive stimulation, we aim to intervene in the disease process to help preserve brain structure and function."
Advancing Toward Pivotal Trial Results
Spectris AD is currently being evaluated in the HOPE pivotal clinical trial, building on the encouraging feasibility data from OVERTURE. The company has also enrolled subjects in a biomarker substudy within the HOPE trial to further evaluate the sensory stimulation device's effects in Alzheimer's patients.
With its non-invasive approach and ease of use, Spectris AD has the potential to offer a more scalable, safer, and cost-effective alternative to existing antibody-based Alzheimer's treatments. The therapy's at-home design could significantly improve accessibility for patients and caregivers managing this devastating neurodegenerative condition.
Cognito's broader clinical platform, Spectris, combines physics, neuroscience, and clinical engineering to advance a new category of therapeutic intervention for neurodegenerative diseases, with ongoing studies evaluating biological effects on brain structure, immune pathways, and connectivity.
