Cognito Therapeutics Phase 2 OVERTURE Study MRI Imaging Analysis Published in Journal of Alzheimer’s Disease

- MRI results Show Noninvasive Gamma Sensory Stimulation May Reduce White Matter and Myelin Loss in Alzheimer’s Disease -

Cognito Therapeutics, a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced today publication of MRI imaging data from its Phase 2 OVERTURE study in the Journal of Alzheimer’s Disease.

The paper, titled: “Noninvasive gamma sensory stimulation may reduce white matter and myelin loss in Alzheimer’s Disease,” reported that patients with mild-moderate Alzheimer’s Disease (AD) who received one-hour daily treatment with Cognito’s gamma sensory device over 6 months showed reduced white matter atrophy and preserved brain myelin content compared to sham treatment in the Phase 2 OVERTURE study.

The MRI treatment effect was highest in the entorhinal region, where white matter connections to the hippocampus are known to be involved in learning and memory and are affected in AD. These findings are consistent with preclinical data demonstrating that optogenetic-stimulated neuronal activity promotes oligodendrogenesis and myelin plasticity (Gibson et al Science 2014).

“The study results suggest that combined visual and auditory gamma-sensory stimulation may modulate neuronal network function in AD in part by reducing white matter atrophy and myelin content loss,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “The entorhinal region MRI outcomes may have significant implications for early AD intervention, considering the crucial afferent connections to the hippocampus and entorhinal cortex.”

White matter degeneration can affect brain function and connectivity, as myelin ensheathes axons and facilitates local and distant neuronal communication. Due to the crucial role of myelin in electrical impulse conduction within neuronal networks, longitudinal evaluation of white matter volume and myelin content could provide valuable insight into AD progression. Cognito therapy employs a proprietary non-invasive approach to induce increased gamma frequency brain activity via specific frequencies of auditory and visual neuromodulation.

MRI data was analyzed from the OVERTURE study (NCT03556280), a randomized, controlled, clinical trial in which active treatment participants received daily, non-invasive, combined visual and auditory, 40 Hz stimulation for six months with Cognito therapy. A subset of OVERTURE participants who meet the inclusion criteria for detailed white matter (N = 38) and myelin content (N = 36) assessments are included in the analysis. White matter volume assessments were performed using T1-weighted MRI, and myelin content assessments were performed using T1-weighted/T2-weighted MRI ratios. Treatment effects on white matter atrophy and myelin content loss were assessed over 6 months.

“White matter atrophy and myelin loss may be a mechanistically important AD treatment target and may identify individuals at high risk of disease progression,” said Brent Vaughan, CEO, Cognito Therapeutics. “Our Phase 2 OVERTURE study imaging results published in the Journal of Alzheimer's Disease, show that our proprietary gamma sensory stimulation reduced white matter atrophy and preserved brain myelin content in patients. We look forward to advancing our Phase 3 HOPE study to bring this novel disease modifying therapy to patients.”

About Cognito Therapeutics

Cognito Therapeutics is a clinical-stage neurotechnology company developing disease-modifying therapeutic approaches to treat neurodegenerative disorders. Its non-invasive neuromodulation platform was developed by MIT Professors and scientific founders Li-Huei Tsai and Ed Boyden. The Company’s lead therapy is currently in a pivotal study (HOPE) in Alzheimer’s Disease and was awarded FDA Breakthrough Device Designation. Cognito is based in Cambridge, MA. For more information, visit www.cognitotx.com. Follow us on Twitter at @cognitotx.

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