Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at CTAD Conference
Cognition Therapeutics presented its Phase 3 clinical development plan for Zervimesine (CT1812), an oral, once-daily small molecule, at the 2025 Clinical Trials on Alzheimer's Disease (CTAD) conference.
Zervimesine is designed to displace toxic protein oligomers that accumulate in the brain with age and bind to neuronal receptors, thereby restoring normal cellular functions and potentially slowing progression of Alzheimer's disease and dementia with Lewy bodies (DLB).
Zervimesine acts by modulating the sigma-2 receptor, which regulates neuronal housekeeping functions impaired in neurodegenerative diseases.
The company is conducting several Phase 2 studies including the START study (in early Alzheimer's disease), SHIMMER study (in DLB), and SHINE study (in mild-to-moderate Alzheimer's) to evaluate safety and efficacy; Phase 2 enrollment targets have been met or completed.
Cognition Therapeutics has received positive feedback from the FDA regarding its Phase 3 trial design for Zervimesine, enabling preparations for advancing development to the next stage.
An Expanded Access Program (EAP) is open for patients with mild-to-moderate DLB who participated in the SHIMMER study or meet eligibility criteria, though zervimesine remains investigational and is not yet approved by regulatory authorities.
Financial support includes a $30 million registered direct offering to fund continued development and clinical trial activities for Zervimesine.
Overall, Zervimesine is a promising investigational candidate targeting age-related toxic protein accumulation and neuronal dysfunction in Alzheimer's and related dementias, with Phase 3 evaluation underway following CTAD presentation.