Cognito Therapeutics Announces First Patient Enrolled in HOPE Biomarker Study

Cognito Therapeutics , a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced today the first patient enrolled in a biomarker substudy within the HOPE pivotal trial .

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Tuesday, January 23, 2024
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Hardware, FDA, Data Management, Other Health, Technology, Pharmaceutical, Mental Health, Medical Devices, Clinical Trials, Science, Biotechnology, Software, Other Science, Health, Research, Patient, HOPE, Therapy, MRI, ARIA, EEG, Failure, Atrophy, Disease, Plasma, Journal, Alzheimer's disease, Safety, Cognition, Biomarker, Cerebrospinal fluid, White matter, Brain, Medical imaging
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UNITED STATES, NORTH AMERICA, MASSACHUSETTS, AD
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ALZHEIMER'S DISEASE, COGNITO THERAPEUTICS, ALZHEIMER’S DISEASE
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  • Cognito Therapeutics , a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced today the first patient enrolled in a biomarker substudy within the HOPE pivotal trial .
  • “The enrollment of the first patient in the HOPE biomarker substudy is a clinical milestone for our company.
  • We are on track to achieve study completion within our projected timelines, with over 240 patients currently enrolled in the HOPE study across 60 active sites across the US,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics.
  • "We are well-positioned to achieve our study timeline goals, as we advance towards potential approval of the first non-pharmacologic disease-modifying therapy for Alzheimer’s Disease."


Cognito Therapeutics, a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced today the first patient enrolled in a biomarker substudy within the HOPE pivotal trial. The HOPE study is evaluating a novel disease-modifying therapy that elicits gamma frequency brain activity through non-invasive sensory stimulation and has the potential to slow the progression of Alzheimer’s Disease, from the comfort of a patient’s home.

“The enrollment of the first patient in the HOPE biomarker substudy is a clinical milestone for our company. We are on track to achieve study completion within our projected timelines, with over 240 patients currently enrolled in the HOPE study across 60 active sites across the US,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. "We are well-positioned to achieve our study timeline goals, as we advance towards potential approval of the first non-pharmacologic disease-modifying therapy for Alzheimer’s Disease."

Brain function depends on continued maintenance of brain structural integrity. In AD, failure to maintain neuronal, synaptic and myelin structures can affect neuronal network function and connectivity required to support cognition and daily function. Gamma frequency brain activity is essential for the maintenance of brain structure and function, and is impaired in AD. The evaluation of MRI, cerebrospinal fluid and plasma biomarkers in the HOPE biomarker substudy will provide key insights into AD progression and may help us see earlier predictive responses to Cognito therapy and may help us better identify patients and new disease areas that respond best to treatment.

“While several experimental drugs focus on addressing well-known amyloid plaques and tau tangles in the brain, Cognito is exploring an innovative, non-invasive medical device designed to target additional factors contributing to Alzheimer's disease, by targeting abnormal electrical activities in the brain,” said Brent Vaughan, CEO, Cognito Therapeutics. “This novel approach presents an opportunity to address Alzheimer's disease using a different modality, offering a potential new treatment option for those affected by this devastating condition.”

Cognito’s Phase 2 OVERTURE study imaging results were recently published in the Journal of Alzheimer's Disease, demonstrating its proprietary gamma sensory stimulation not only reduced white matter atrophy but also preserved brain myelin content in patients with mild-moderate AD.

Phase 2 OVERTURE open-label extension study data reported that Cognito’s non-invasive treatment reduces brain atrophy and ADCS-ADL decline over 18 months, consistent with disease modification. No ARIA was observed and participant safety was confirmed over 18 months. The study confirmed real-time evidence of brain target modulation via EEG, and demonstrated biological mechanism of action via MRI brain imaging.

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

About Alzheimer’s Disease

Alzheimer’s disease is a multifactorial progressive neurodegenerative disease that disrupts synaptic and neuronal activity and network oscillations and is associated with neuronal loss, brain atrophy, and cognitive and functional decline. It is the seventh leading cause of death among all Americans and the fifth leading cause of death among Americans aged 65 and older.

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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