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FDA confirms alignment on key elements of Phase 3 study for zervimesine in dementia with Lewy bodies
CGTXCognition Therapeutics Inc
Cognition Therapeutics announced that the U.S. Food and Drug Administration has confirmed alignment on critical design elements for a pivotal Phase 3 registrational trial of its lead candidate, zervimesine (CT1812), in patients with dementia with Lewy bodies. The planned study will enroll participants with mild-to-moderate disease, randomizing them to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. Primary endpoints include the Neuropsychiatric Inventory-2 (NPI-2) to measure hallucinations and delusions, while a key secondary endpoint assesses daily function using the ADCS-ADL scale. The company is currently finalizing the protocol based on these collaborative discussions with FDA divisions.