NCT05397639Active, not recruitingPhase 3
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 375 (estimated)
- First submitted
- 25 May 2022
- Start date
- 1 Nov 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Suven Life Sciences Limited
- Diseases
- Alzheimer disease
- NCT number
- NCT05397639
- EudraCT number
- 2021-003405-22
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 375
- From 1 Nov 2022 to the primary completion date, Dec 2026
- 44 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.
Who the study is looking for
- 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).
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Hospital Center Rijeka Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
| Polyclinic Neuron Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Klinika za psihijatriju "Vrapče" Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| University Hospital Center Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| EMC Silesia Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Medyczne Silmedic Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Neuro-Medic Janusz Zbrojkiewicz Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Medycyna Milorzab sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Leczenia Zaburzen Pamieci Affidea Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| FutureMeds Warszawa Centrum Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| ClinHouse Centrum Medyczne Coordinator of this site? Confirm its status | Zabrze | Poland | Unknown status |
| Clinical Hospital Center Dragisa Misovic Dedinje Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Special Hospital for Psychiatric Diseases Coordinator of this site? Confirm its status | Kovin | Serbia | Unknown status |
| University Clinical Center Kragujevac, Clinic for Psychiatry Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| University Clinical Center Nis, Clinic for neurology Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Clinical Centre of Vojvodina, Clinic of Neurology Coordinator of this site? Confirm its status | Novi Sad | Serbia | Unknown status |
| Dent Neurologic Institute Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| Advanced Research Center, Inc. Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Velocity Clinical Research, Cleveland Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Ralph H. Johnson VA Health Care System Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Re:Cognition Health Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Insight Hospital and Medical Center Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Midlands Neurology and Pain Associates Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| ATP Clinical Research, Inc. Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Velocity Clinical Research, Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| Leading Edge Research LA, LLC Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| Re:Cognition Health Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Neuro-Pain Medical Center Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Neurology Center of North Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Trial Network Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mary S Easton Center for Alzheimer's Research and Care UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Miami Jewish Health Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Novel Clinical Research Center, LLC. Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Allied Biomedical Research Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Brainstorm Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| CCM Clinical Research Group Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Central Miami Medical Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Combined Research Orlando Phase I-IV Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Quantum Laboratories Inc Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| Ki Health Partners, LLC Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| Ocean Medical Research Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.