Cognition Therapeutics Announces Alignment with FDA on Pivotal Phase 3 Trial of Zervimesine (CT1812) in Dementia with Lewy Bodies
Cognition Therapeutics has reached alignment with the FDA on key elements of a pivotal Phase 3 trial of zervimesine (CT1812) in dementia with Lewy bodies, covering patient selection, dose, duration, and endpoints. The registrational study will enroll mild-to-moderate DLB patients randomized to 100 mg once-daily oral zervimesine or placebo for nine months, with the NPI-2 hallucinations/delusions measure as primary endpoint and ADCS-ADL as key secondary.
Key figures
- Drug Name
- zervimesine (CT1812)
- Phase Of Trial
- Phase 3
- Dose
- 100 mg once-daily oral
- Trial duration
- nine months
- Primary endpoint
- NPI-2 (hallucinations and delusions)
- Nih grant funding
- $200 million
- Key secondary endpoint
- ADCS-ADL
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