Cognition aligns with FDA on pivotal Lewy body dementia trial

Cognition Therapeutics ($CGTX) said it reached agreement with the FDA on key elements of a planned pivotal Phase 3 study of zervimesine, also known as CT1812, in dementia with Lewy bodies. The proposed trial would compare a 100-milligram daily oral dose with placebo for nine months in patients with mild to moderate disease.

The primary assessment would measure hallucinations and delusions using the NPI-2 scale, with daily functioning measured by ADCS-ADL as a key secondary endpoint. Agreement covers patient selection, dosing, duration and endpoints, giving the company a clearer framework for completing its protocol. The announcement concerns trial design rather than a successful clinical outcome: the registrational study still must be conducted, and zervimesine's efficacy and safety in this setting remain to be established.

Sources:

• ir.cogrx.com