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NCT05397639 · ClinicalTrials.gov registry record · Phase 3
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
A Phase 3 study of Agitation and Alzheimer's Type Dementia, sponsored by Suven Life Sciences Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
- 20
- Study locations
NCT05397639: Recruiting Phase 3 study of Agitation and Alzheimer's Type Dementia, sponsored by Suven Life Sciences Limited.
NCT05397639 is a Phase 3 study of Agitation and Alzheimer's Type Dementia that is actively recruiting participants, run by Suven Life Sciences Limited. The registered enrollment target is 375 participants, above the 164-participant average among 8 other Agitation trials with a reported enrollment target (129% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05397639, a Phase 3 study of Agitation and Alzheimer's Type Dementia, is actively recruiting participants, sponsored by Suven Life Sciences Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Change in CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains (physical aggression, excessive motor activity, and verbal aggression). CMAI is a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate worsening agitation.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Masupirdine 50 mg
- DRUG Masupirdine 100 mg
Study Locations (20)
Florida
- Allied Biomedical Research Institute - Miami
- Central Miami Medical Institute - Miami
- CCM Clinical Research Group - Miami
- Miami Jewish Health - Miami
- Novel Clinical Research Center, LLC. - Miami
- Brainstorm Research - Miami
- Combined Research Orlando Phase I-IV - Orlando
- Quantum Laboratories Inc - Pompano Beach
California
- Advanced Research Center, Inc. - Anaheim
- ATP Clinical Research, Inc. - Costa Mesa
- Leading Edge Research LA, LLC - Encino
- Neuro Pain Medical Center - Fresno
- Neurology Center of North Orange County - Fullerton
- Mary S Easton Center for Alzheimer's Research and Care UCLA - Los Angeles
Illinois
- Re:Cognition Health - Chicago
- Insight Hospital and Medical Center Chicago - Chicago
New York
- Dent Neurologic Institute - Amherst
- Velocity Clinical Research, Syracuse - East Syracuse
Connecticut
- Ki Health Partners, LLC - Stamford
New Jersey
- Ocean Medical Research - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT05397639 shows while recruiting
NCT05397639 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 164-participant average among 8 other Agitation trials with a reported enrollment target (129% higher).
The record links to 2 conditions, with Agitation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05397639 names 20 study sites across 6 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05397639 about?
NCT05397639 is a clinical study titled "Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type". 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.
What is the current status of trial NCT05397639?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2022-11-01. Estimated completion is 2026-12.
What conditions does trial NCT05397639 study?
This clinical trial studies the following conditions: Agitation, Alzheimer's Type Dementia.
What interventions are being tested in trial NCT05397639?
The interventions under investigation include: Placebo (DRUG), Masupirdine 50 mg (DRUG), Masupirdine 100 mg (DRUG).
Who is sponsoring clinical trial NCT05397639?
This trial is sponsored by Suven Life Sciences Limited, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05397639 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Agitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05397639's enrollment target sits among peer trials
375 2nd of 8 the highest of 8 other Agitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Agitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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