Suven Life Sciences has randomized first patient in the Phase-3 global clinical trial of Masupirdine for the treatment of agitation in patients with dementia of the Alzheimer's type. The trial is a multicenter, randomized, double-blind, placebo-controlled study planned across 50 sites in the North America and Europe. The study will enroll around 375 patients who will be randomized in a 1:1:1 ratio to receive masupirdine either 50 mg QD or 100 mg QD or placebo QD for 12 weeks. The primary outcome measure is Cohen-Mansfield Agitation Inventory (CMAI) - Change in the CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains from baseline to Week 12. Key secondary outcome measure is modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) scale as related to the agitation. Topline data from the trial is expected to be available by early 2025.
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