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

September 12, 2026 updated by: Suven Life Sciences Limited

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 375 participants will be enrolled at approximately 50 centers worldwide.

Study medication will be administered orally once-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Center Rijeka
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb
      • Zagreb, Croatia, 10000
        • Polyclinic Neuron
      • Zagreb, Croatia, 10090
        • Klinika za psihijatriju Vrapce
  • Poland
      • Zabrze, Poland, 41-807
        • ClinHouse Centrum Medyczne
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-227
        • Medycyna Milorzab sp. z o.o.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-215
        • FutureMeds Warszawa Centrum
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • MTZ Clinical Research Powered by PRATIA
      • Warsaw, Masovian Voivodeship, Poland, 04-148
        • Centrum Leczenia Zaburzen Pamieci Affidea
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-282
        • Centrum Medyczne Silmedic Sp z o o
      • Katowice, Silesian Voivodeship, Poland, 40-353
        • EMC Silesia sp. z o.o.
      • Katowice, Silesian Voivodeship, Poland, 40-686
        • Neuro-Medic Janusz Zbrojkiewicz
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Dragisa Misovic Dedinje
      • Kovin, Serbia, 26220
        • Special Hospital for Psychiatric Diseases
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac, Clinic for Psychiatry
      • Niš, Serbia, 18000
        • University Clinical Center Nis, Clinic for neurology
      • Novi Sad, Serbia, 21000
        • Clinical Centre of Vojvodina, Clinic of Neurology
  • United States
    • California
      • Anaheim, California, United States, 92805-5854
        • Advanced Research Center, Inc.
      • Costa Mesa, California, United States, 92626-4607
        • ATP Clinical Research, Inc.
      • Encino, California, United States, 91316
        • Leading Edge Research LA, LLC
      • Fresno, California, United States, 93710-5473
        • Neuro Pain Medical Center
      • Fullerton, California, United States, 92835-1040
        • Neurology Center of North Orange County
      • Los Angeles, California, United States, 90095
        • Mary S Easton Center for Alzheimer's Research and Care UCLA
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Health Partners, LLC
    • Florida
      • Miami, Florida, United States, 33133
        • CCM Clinical Research Group
      • Miami, Florida, United States, 33176
        • Brainstorm Research
      • Miami, Florida, United States, 33137
        • Miami Jewish Health
      • Miami, Florida, United States, 33125
        • Central Miami Medical Institute
      • Miami, Florida, United States, 33125-2607
        • Allied Biomedical Research Institute
      • Miami, Florida, United States, 33143
        • Novel Clinical Research Center, LLC.
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando Phase I-IV
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories Inc
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Insight Hospital and Medical Center Chicago
      • Chicago, Illinois, United States, 60611
        • Re:Cognition Health
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Ocean Medical Research
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research, Syracuse
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Velocity Clinical Research, Cleveland
    • South Carolina
      • Charleston, South Carolina, United States, 29401-1113
        • Ralph H. Johnson VA Health Care System
      • Columbia, South Carolina, United States, 29205
        • Midlands Neurology and Pain Associates
    • Texas
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
      • Fort Worth, Texas, United States, 76104
        • Re:Cognition Health
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77030-4202
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose Masupirdine Arm
Tablet
Drug: Masupirdine 50 mg
Tablet, Once Daily
Other Names:
  • SUVN-502
Experimental: High Dose Masupirdine Arm
Tablet
Drug: Masupirdine 100 mg
Tablet, Once Daily
Other Names:
  • SUVN-502
Placebo Comparator: Placebo
Tablet
Drug: Placebo
Matching Placebo Tablet, Once Daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: From Baseline to Week 12 visit
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.
From Baseline to Week 12 visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)
Time Frame: From Baseline to Week 12 visit
Change in mADCS-CGI-C. The mADCS-CGI-C is a modification of the ADCS-CGI-C instrument that focuses specifically on agitation. It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7. The range is from 1 to 7. Higher scores indicate worsening agitation.
From Baseline to Week 12 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suven Life Sciences Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP3S1502HT6
  • 2021-003405-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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