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Data reveal significant alterations in 110 proteins linked to critical biological pathways associated with the disease.
March 5, 2025
By: Michael Barbella
Managing Editor
New study data shows Cognito Therapeutics’ non-invasive medical device, Spectris, triggers myelin and synaptic biomarker changes in Alzheimer’s patients.
Published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 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). The trial was completed as part of the FLICKER clinical trial 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.
“This study further validates the potential of Spectris to target core mechanisms driving Alzheimer’s pathology,” Cognito Therapeutics CEO Christian Howell said. “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.”
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 four and eight 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.
Related: Cognito Therapeutics Releases Cost-Effectiveness Analysis of Spectris Therapy“These findings build on prior clinical evidence showing that Spectris preserves white matter and myelin integrity, reduces brain atrophy, and improves cognitive function,” Cognito Therapeutics Chief Medical Officer Ralph Kern M.D., stated. “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.”
Cambridge, Mass.-based 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 in an effort to slow brain atrophy and functional decline in Alzheimer’s disease. Cognito is developing technology-driven interventions to address unmet needs in CNS disease treatment.
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