Expanded Access Program (EAP)
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Cognition Therapeutics Extends Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Globenewswire· 2026-02-05 12:30
Core Viewpoint - Cognition Therapeutics, Inc. has extended the duration of its expanded access program for dementia with Lewy bodies, allowing participants several more months of treatment beyond the initial twelve months [1]. Group 1: Expanded Access Program (EAP) - The EAP has been operational since June 2025 and aims to gather additional long-term safety data [2]. - Feedback from participants and their care partners has been favorable, highlighting the program's operational aspects that reduce travel for patients [2][3]. - A total of 32 individuals are enrolled across eight sites, each receiving 100 mg of oral zervimesine daily [2]. Group 2: Clinical Development and Regulatory Engagement - The EAP is part of a broader clinical development program for dementia with Lewy bodies, which includes the Phase 2 SHIMMER study [3]. - Cognition Therapeutics held a Type C meeting with the FDA on January 21, 2026, to discuss findings from the SHIMMER study, focusing on clinically meaningful endpoints for future studies [3]. Group 3: Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [5]. - The company has completed Phase 2 studies for its lead candidate, zervimesine, in various conditions including dementia with Lewy bodies and mild-to-moderate Alzheimer's disease [5].
Philanthropic Donor Funds Cognition Therapeutics’ Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Globenewswire· 2025-06-03 11:30
Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [7] - The company is currently investigating its lead candidate, zervimesine (CT1812), in clinical programs for dementia with Lewy bodies (DLB) and Alzheimer's disease [7] Expanded Access Program (EAP) - Cognition has received an anonymous philanthropic donation to fund an expanded access program for individuals with dementia with Lewy bodies [2] - The EAP will provide participants with 100 mg of oral zervimesine daily for approximately one year, starting with around 30 individuals [4] - The first site activated for the EAP is the Banner Sun Health Research Institute in Arizona, with Dr. David Shprecher as the primary investigator [2][5] Clinical Study and Collaboration - The EAP is based on the Phase 2 SHIMMER study, where zervimesine was administered to DLB patients [2] - Dr. James E. Galvin will serve as the lead investigator for the EAP, bringing his experience from the SHIMMER study [3][4] - The program aims to onboard additional participating sites rapidly to begin treatment for eligible patients [3] Future Prospects - Cognition aims to expand the EAP to accommodate more patients as funding and drug supply allow [4] - The company believes zervimesine can regulate impaired pathways in neurodegenerative diseases through its interaction with the sigma-2 receptor [7]