Cognito Therapeutics Announces Non-invasive Neuromodulation Therapy Delays Alzheimer’s Disease Progression

- New peer-reviewed publication demonstrates that Spectris AD™ delays cognitive decline, brain atrophy, and functional loss in participants with mild-to-moderate Alzheimer’s disease

Cognito Therapeutics, a pioneering neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, today announced new results from a post hoc analysis of its OVERTURE feasibility clinical trial showing that its investigational therapy, Spectris AD™, significantly slows the progression of Alzheimer’s disease.

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Cognito Spectris investigational device. Image credit: Cognito Therapeutics

Spectris AD™ uses non-invasive neuromodulation through synchronized light and sound stimulation at a gamma frequency (40Hz) to restore brain electrical activity that is disrupted in Alzheimer’s disease (AD). The therapy is designed for at-home daily use and has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Published in Alzheimer’s & Dementia: Translational Research and Clinical Interventions, titled “Time Saved in Activities of Daily Living and Whole-Brain Volume: Post Hoc Analysis of a Randomized Feasibility Trial of Gamma Oscillation Treatment in Participants with Mild or Moderate Alzheimer’s Disease,” the analysis found that treatment with Spectris AD™ was associated with meaningful “time saved” across key measures of cognition, daily function, and brain structure on MRI, compared to sham treatment. The concept of “time saved” represents how much longer treated patients maintain critical functions before reaching the same level of decline observed in untreated individuals, offering a patient-centric measure of therapeutic impact.

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. In the initial six-month controlled phase, daily one-hour Spectris AD™ treatment was associated with 4.83 months of preserved ability to perform daily activities, 4.56 months of delayed cognitive decline, and 4.09 months of delayed whole-brain atrophy.

These benefits became more pronounced over the full 12-month study period, underscoring the potential of Spectris AD™ to meaningfully delay Alzheimer’s progression and preserve quality of life, where participants treated with the Spectris AD™ device experienced a clinically meaningful delay in disease progression compared to those who received sham treatment, preserving cognitive and functional abilities for longer. Patients originally assigned to Spectris AD™, who were subsequently treated with SPECTRIS in the open label extension study (OLE), took longer to progress to the same levels of decline that the sham group experienced in 6 months, corresponding to 10 months preservation in MMSE, 9 months in ADCS-ADL and 7.5 months in whole brain atrophy.

“Our brains are electrical systems, and Alzheimer’s disrupts the rhythms that govern memory, cognition, and our ability to function,” said Christian Howell, CEO, 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. These findings show the potential to meaningfully slow disease progression by leveraging the potential of neuromodulation.”

“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, 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. This may ultimately enable patients with Alzheimer’s to maintain meaningful interaction and independence for a longer period.”

Spectris AD™ is currently being evaluated in the HOPE pivotal clinical trial and is designed for convenient, daily use at home. In the OVERTURE study, the therapy demonstrated a strong adverse event profile, strong adherence rates of over 80%, and no observed risk of ARIA. 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 antibody-based Alzheimer’s treatments.

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 expanding data evaluating biological effects on brain structure, immune pathways, and connectivity, the company is building a comprehensive understanding of how non-invasive gamma stimulation may modify the course of neurodegenerative disease broadly.

For more information about the HOPE study, visit www.hopestudyforad.com.

About Cognito Therapeutics

Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris AD™, uses non-invasive auditory and visual neuromodulation to enhance gamma frequency brain activity, with the goal of slowing brain atrophy and functional decline in Alzheimer's disease. Cognito is committed to developing transformative, technology-driven interventions to address unmet needs in the treatment of CNS diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx.

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