Cognito Therapeutics Announces Spectris™ Treatment Demonstrates Myelin and Synaptic Biomarker Changes in Alzheimer’s Disease

- Peer-reviewed findings published in Alzheimer's & Dementia: Translational Research & Clinical Interventions

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, today announced the publication of a study in Alzheimer's & Dementia: Translational Research & Clinical Interventions that highlights myelin and synaptic biomarker changes in Alzheimer’s patients treated with its non-invasive medical device, Spectris™.

The study, titled “CSF Proteomics Reveals Changes in Myelin and Synaptic Biology Following Spectris™ Treatment,” offers compelling evidence of Spectris™’ ability to modulate core biological pathways involved in Alzheimer’s disease (AD). Completed as part of the FLICKER clinical trial (NCT03543878), in collaboration with Emtherapro Inc, Georgia Institute of Technology and Emory University, the research demonstrated that daily Spectris™ therapy, which uses non-invasive sensory stimulation to evoke steady-state brain gamma oscillations, resulted in significant cerebrospinal fluid (CSF) biomarker changes in pathways critical to AD, including myelination, synaptic function, lipid metabolism, and neuroimmune regulation.

Unbiased proteomic analysis of CSF samples from participants with amyloid-positive MCI (n=10) was conducted from the FLICKER clinical trial. Participants used the Cognito Therapeutics medical device (Spectris™) and had evoke steady-state gamma brain oscillations confirmed with EEG. Participants were instructed to use the device daily for an hour each day during the trial. CSF was collected prior to the start of stimulation and after 4 and 8 weeks of treatment. The proteome was analyzed using tandem-mass tag mass spectrometry.

Results revealed significant alterations in 110 proteins linked to critical biological pathways associated with AD, including myelination, synaptic function, lipid metabolism, and neuroimmune regulation. Notably, many protein changes were observed in the opposite direction of those associated with AD progression, suggesting a therapeutic effect of Spectris™ on the underlying disease biology.

“This study further validates the potential of Spectris™ to target core mechanisms driving Alzheimer’s pathology,” said Christian Howell, CEO, Cognito Therapeutics. “By modulating key biological pathways through gamma oscillations, Spectris™ has the opportunity to not just slow disease progression but to meaningfully improve the lives of patients with Alzheimer’s.”

“These findings build on prior clinical evidence showing that Spectris™ preserves white matter and myelin integrity, reduces brain atrophy, and improves cognitive function,” said Ralph Kern MD MHSc, Chief Medical Officer, Cognito Therapeutics. “By evoking steady-state gamma oscillations through sensory stimulation, Spectris™ demonstrates the ability to target and influence key biological pathways central to Alzheimer’s disease. The observed modulation of CSF proteins mapped to Alzheimer’s disease brain proteome modules further underscores a direct connection between this treatment and improved cellular functions critical to combating neurodegeneration.”

About Cognito Therapeutics

Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris™, 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.