Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Agitation, Alzheimer's Type Dementia

In brief

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Key facts

Study ID

NCT05397639

Run by

Suven Life Sciences Limited

People needed

375

Starts

2022-11-01

Expected to finish

2026-12-01

Last updated by the study team

2026-01-12

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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.

Where it is running

• Advanced Research Center, Inc. — Anaheim, California, United States (enrolling)
• ATP Clinical Research, Inc. — Costa Mesa, California, United States (enrolling)
• Leading Edge Research LA, LLC — Encino, California, United States (enrolling)
• Neuro Pain Medical Center — Fresno, California, United States (enrolling)
• Neurology Center of North Orange County — Fullerton, California, United States (enrolling)
• Mary S Easton Center for Alzheimer's Research and Care UCLA — Los Angeles, California, United States (enrolling)
• Ki Health Partners, LLC — Stamford, Connecticut, United States (enrolling)
• Allied Biomedical Research Institute — Miami, Florida, United States (enrolling)
• Central Miami Medical Institute — Miami, Florida, United States (enrolling)
• CCM Clinical Research Group — Miami, Florida, United States (enrolling)
• Miami Jewish Health — Miami, Florida, United States (enrolling)
• Novel Clinical Research Center, LLC. — Miami, Florida, United States (enrolling)
• Brainstorm Research — Miami, Florida, United States (enrolling)
• Combined Research Orlando Phase I-IV — Orlando, Florida, United States (enrolling)
• Quantum Laboratories Inc — Pompano Beach, Florida, United States (enrolling)
• Re:Cognition Health — Chicago, Illinois, United States (enrolling)
• Insight Hospital and Medical Center Chicago — Chicago, Illinois, United States (enrolling)
• Ocean Medical Research — Toms River, New Jersey, United States (enrolling)
• Dent Neurologic Institute — Amherst, New York, United States (enrolling)
• Velocity Clinical Research, Syracuse — East Syracuse, New York, United States (enrolling)
• Velocity Clinical Research, Cleveland — Beachwood, Ohio, United States (enrolling)
• Ralph H. Johnson VA Health Care System — Charleston, South Carolina, United States (enrolling)
• Midlands Neurology and Pain Associates — Columbia, South Carolina, United States (enrolling)
• Gadolin Research — Beaumont, Texas, United States (enrolling)
• Re:Cognition Health — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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