To evaluate the efficacy, and safety of Masupirdine targeting agitation in patients with dementia of Alzheimer’s type

Alzheimer’s disease (AD) is the most common cause of dementia, accounting for an estimated 60% to 80% of cases. Neuropsychiatric symptoms (NPS) are the non-cognitive manifestations observed in 90% of people with AD over the course of their illness. Among NPS, agitation is one of the most common symptoms occurring in about 3/4^th of AD patients. It negatively impacts the quality of life not only for the patients but also for their families and friends.

Masupirdine is a pure, potent, and orally active serotonin-6 (5-HT₆) receptor antagonist. Masupirdine was evaluated in animal models to assess its effects on behavior and modulation of brain neurotransmitters. Clinical evidence for potential efficacy of Masupirdine on agitation was generated from post hoc analyses of a Phase-2 study targeting cognition in AD patients. To confirm the effects of Masupirdine, a Phase-3 global study to evaluate the efficacy and safety of Masupirdine in patients with agitation in dementia of the Alzheimer’s type (NCT05397639) was initiated. About 375 patients from the USA and Europe will be recruited for the study. Patients will receive either 50 mg or 100 mg Masupirdine or placebo for 12 weeks. Cohen-Mansfield Agitation Inventory items scores aligning to the IPA agitation criteria domains is the primary endpoint.

The observations from the animal models and post hoc analyses of Phase-2 study support the potential beneficial effects of Masupirdine on agitation. Masupirdine was well tolerated in patients with moderate AD dementia. The Phase-3 study is currently underway in the USA and Europe.

Results from the Phase-3 study will inform the utility of Masupirdine in treating agitation in patients with dementia of the Alzheimer's type.