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Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Surpasses 50% Enrollment Target
Globenewswire· 2025-07-01 11:30
Core Viewpoint - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has surpassed 50% enrollment, indicating strong interest in their investigational drug zervimesine for treating early Alzheimer's disease [1][2][3] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [9][10] - The company is currently advancing zervimesine (CT1812), an oral treatment for Alzheimer's disease and dementia with Lewy bodies [5][9] Study Details - The START Study aims to enroll up to 540 individuals with mild Alzheimer's disease, who will receive either zervimesine or a placebo for 18 months [3][7] - The study is supported by an $81 million grant from the National Institute of Aging (NIA) and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) [1][8] Treatment Mechanism - Zervimesine is designed to target the toxic effects of protein buildup in the brain, specifically Aβ and ɑ-synuclein, which are associated with neurodegenerative diseases [5][10] - The treatment has shown promise in previous studies, with the Phase 2 'SHINE' Study indicating a 38% slowing of cognitive decline compared to placebo, and a 95% slowing in participants with lower levels of p-tau217 [4][10] Clinical Significance - The START Study is significant as it targets participants who are just beginning to show signs of cognitive loss, potentially allowing for earlier intervention [4][7] - The study will assess cognitive function and safety using validated tools, contributing to the understanding of zervimesine's efficacy in early Alzheimer's disease [7][8]
Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB)
Globenewswire· 2025-06-25 11:30
Core Insights - Cognition Therapeutics, Inc. is advancing zervimesine (CT1812) into a Phase 3 program for mild-to-moderate Alzheimer's disease and has filed for breakthrough therapy designation for dementia with Lewy bodies (DLB) [1][2] Group 1: Clinical Development - An end-of-Phase 2 meeting with the FDA is scheduled for July 9, 2025, to discuss the Phase 2 'SHINE' study results and plans for a Phase 3 program for zervimesine in Alzheimer's disease [1] - The company is also progressing with an expanded access program for zervimesine in DLB, which has garnered high interest from former SHIMMER study participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating neurodegenerative diseases, specifically Alzheimer's disease and DLB, by potentially interrupting the toxic effects of protein buildup in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] Group 3: Company Overview - Cognition Therapeutics, Inc. focuses on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and has completed Phase 2 studies for zervimesine in multiple conditions [6]
Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer's Disease and Dementia with Lewy Bodies (DLB)
GlobeNewswire News Room· 2025-06-25 11:30
Core Viewpoint - Cognition Therapeutics, Inc. is advancing its investigational drug zervimesine (CT1812) for the treatment of mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB), with an end-of-Phase 2 meeting scheduled with the FDA to discuss Phase 2 study results and plans for a Phase 3 program [1][2][8] Group 1: Clinical Development - The company will hold an end-of-Phase 2 meeting with the FDA on July 9, 2025, to review the Phase 2 'SHINE' study results of zervimesine in Alzheimer's disease [1] - Cognition is also moving forward with plans for a registrational program for DLB based on positive results from the Phase 2 'SHIMMER' study [2] - An expanded access program for zervimesine in DLB is underway, with high interest from former SHIMMER participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an oral, once-daily investigational drug targeting neurodegenerative diseases, specifically Alzheimer's and DLB, by potentially interrupting the toxic effects of harmful proteins in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] - The USAN Council has adopted zervimesine as the official name for CT1812 [5] Group 3: Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in multiple conditions, including DLB and Alzheimer's disease, and is currently conducting an ongoing Phase 2 study in early Alzheimer's disease [6]