Cognition Therapeutics presented a registrational plan for its investigational treatment zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, the company said.
The proposed Phase 3 program, designed in consultation with U.S. Food and Drug Administration (FDA), will enrol adults with mild-to-moderate Alzheimer’s who show lower plasma levels of the biomarker p-tau217 at screening. The company believes this biomarker-based enrichment will identify patients most likely to benefit from zervimesine, based on analyses from its Phase 2 “SHINE” trial.
Under the plan, participants will receive a daily 100 mg oral dose of zervimesine or placebo for six months in two randomized trials. The design includes biomarker and imaging assessments, and participants will be eligible for open-label extension after the controlled phase.
The company also intends to engage European Medicines Agency (EMA) in early 2026 to align its global Alzheimer’s and Dementia with Lewy bodies (DLB) strategies.
Cognition described zervimesine as an investigational, once-daily oral therapy designed to counter neurodegeneration by displacing toxic protein oligomers that damage neurons—a mechanism relevant to Alzheimer’s disease and DLB.
