CAMBRIDGE, Mass. – Cognito Therapeutics has announced new clinical findings showing that its investigational device, Spectris AD™, significantly delays the progression of Alzheimer’s disease in patients with mild to moderate symptoms. The non-invasive neuromodulation therapy, which uses synchronized light and sound stimulation, demonstrated measurable benefits in cognitive preservation, brain structure, and daily functioning.
The results come from a post hoc analysis of Cognito’s OVERTURE feasibility trial, recently published in Alzheimer’s & Dementia: Translational Research and Clinical Interventions. In the six-month randomized, controlled phase of the study, participants who received daily one-hour treatments with Spectris AD™ retained their cognitive and functional abilities for notably longer than those who received a sham treatment. Specifically, the therapy delayed the loss of daily function by nearly five months, cognitive decline by 4.6 months, and whole-brain atrophy by just over four months.
These effects were amplified during the 12-month open-label extension of the trial. Patients originally treated with Spectris AD™ experienced extended delays in disease progression compared to those initially given the placebo, with preserved abilities equating to up to 10 months on standard assessments like the Mini-Mental State Examination (MMSE) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL).
The device works by delivering synchronized gamma-frequency (40Hz) stimulation to restore disrupted neural oscillations—rhythmic brain activity often impaired in Alzheimer’s patients. Designed for home use, Spectris AD™ has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
“Our brains are fundamentally electrical systems,” said Christian Howell, CEO of Cognito Therapeutics. “Spectris AD™ targets those disrupted rhythms in Alzheimer’s using a physics-based approach rather than pharmaceuticals, potentially preserving memory, cognition, and independence for longer.”
Chief Medical Officer Dr. Ralph Kern emphasized that this non-invasive therapy aims to directly intervene in the disease process: “By restoring natural neural oscillations, we hope to preserve brain structure and delay functional decline in a meaningful way.”
The therapy is currently being evaluated in HOPE, a pivotal clinical trial, and has so far shown high adherence rates (above 80%) and a favorable safety profile, with no observed cases of ARIA (amyloid-related imaging abnormalities). With its ease of use and promising results, Spectris AD™ may offer a safer and more accessible alternative to antibody-based treatments.
Cognito Therapeutics continues to expand research into the broader biological effects of its Spectris™ platform, combining physics, neuroscience, and engineering to reshape the treatment landscape for neurodegenerative diseases.
