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Masupirdine treatment for agitation in Alzheimer's dementia

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Phase 3 Interventional Suven Life Sciences Limited · NCT05397639

This study is testing if a new medication called masupirdine can help reduce agitation in people with Alzheimer's dementia.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment375 (estimated)
Ages50 Years to 90 Years
SexAll
SponsorSuven Life Sciences Limited Industry-sponsored
Locations44 sites (Anaheim, California and 43 other locations)
Trial IDNCT05397639 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine in treating agitation in individuals diagnosed with Alzheimer's type dementia. Approximately 375 participants will be enrolled across 50 centers worldwide, receiving either masupirdine or a placebo for 12 weeks. Participants will be screened for eligibility based on specific criteria, including confirmed agitation and cognitive assessment scores.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Alzheimer's type dementia who exhibit confirmed agitation.

Not a fit: Patients with agitation stemming from non-Alzheimer's dementia or other psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce agitation in patients with Alzheimer's dementia, improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating agitation in dementia, but the specific use of masupirdine is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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 this trial is running

Anaheim, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AgitationAlzheimer's Type DementiaMasupirdineSUVN-502Phase 3
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.