NCT05397639 · Phase 3 · ACTIVE NOT RECRUITING
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
This trial is testing whether masupirdine, a daily pill, can ease agitation in people who already have Alzheimer's dementia. Agitation can mean restlessness, irritability, or verbal and physical outbursts. Researchers compare two doses against a placebo. It is a Phase 3 trial, a late-stage test of whether the drug works and is safe, but not yet proven or approved.
You may qualify if
- Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.
- Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE).
You're excluded if
- Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)
- Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-15