AgitationPhase 3NCT05397639
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
A Phase 3 study testing Masupirdine 50 mg and Masupirdine 100 mg in people with Agitation and Alzheimer's Type Dementia, run by Suven Life Sciences Limited at 44 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Agitation, Alzheimer's Type Dementia
- What is being tested?
- Masupirdine 50 mg and Masupirdine 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 44 sitesin 4 countries
- Study dates
- 1 Nov 2022to Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States27 sites
Dent Neurologic Institute
Amherst, New York, 14226
Advanced Research Center, Inc.
Anaheim, California, 92805-5854
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Gadolin Research
Beaumont, Texas, 77702
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401-1113
Re:Cognition Health
Chicago, Illinois, 60611
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
Midlands Neurology and Pain Associates
Columbia, South Carolina, 29205
ATP Clinical Research, Inc.
Costa Mesa, California, 92626-4607
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Leading Edge Research LA, LLC
Encino, California, 91316
Re:Cognition Health
Fort Worth, Texas, 76104
Neuro Pain Medical Center
Fresno, California, 93710-5473
Neurology Center of North Orange County
Fullerton, California, 92835-1040
Baylor College of Medicine
Houston, Texas, 77030-4202
Clinical Trial Network
Houston, Texas, 77074
Mary S Easton Center for Alzheimer's Research and Care UCLA
Los Angeles, California, 90095
Allied Biomedical Research Institute
Miami, Florida, 33125-2607
Central Miami Medical Institute
Miami, Florida, 33125
CCM Clinical Research Group
Miami, Florida, 33133
Miami Jewish Health
Miami, Florida, 33137
Novel Clinical Research Center, LLC.
Miami, Florida, 33143
Brainstorm Research
Miami, Florida, 33176
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
Quantum Laboratories Inc
Pompano Beach, Florida, 33064
Ki Health Partners, LLC
Stamford, Connecticut, 06905
Ocean Medical Research
Toms River, New Jersey, 08755
Poland8 sites
Centrum Medyczne Silmedic Sp z o o
Katowice, Silesian Voivodeship, 40-282
EMC Silesia Sp. z o.o.
Katowice, Silesian Voivodeship, 40-353
Neuro-Medic Janusz Zbrojkiewicz
Katowice, Silesian Voivodeship, 40-686
Medycyna Milorzab sp. z o.o.
Lodz, Lódzkie, 90-227
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215
MTZ Clinical Research powered by Pratia
Warsaw, Masovian Voivodeship, 02-172
Centrum Leczenia Zaburzen Pamieci Affidea
Warsaw, Masovian Voivodeship, 04-148
ClinHouse Centrum Medyczne
Zabrze, 41-807
Serbia5 sites
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, 11000
Special Hospital for Psychiatric Diseases
Kovin, 26220
University Clinical Center Kragujevac, Clinic for Psychiatry
Kragujevac, 34000
University Clinical Center Nis, Clinic for neurology
Niš, 18000
Clinical Centre of Vojvodina, Clinic of Neurology
Novi Sad, 21000
Croatia4 sites
Clinical Hospital Center Rijeka
Rijeka, 51000
Polyclinic Neuron
Zagreb, 10000
University Hospital Center Zagreb
Zagreb, 10000
Klinika za psihijatriju Vrapce
Zagreb, 10090
About this study
Official title: 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.
Read the 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.
- Conditions
- Agitation, Alzheimer's Type Dementia
- Being tested
- Masupirdine 50 mg, Masupirdine 100 mg, Placebo
- Keywords
- Masupirdine, SUVN-502, Phase 3, Agitation
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masupirdine 50 mgDrug
Also called SUVN-502
Tablet, Once Daily
Masupirdine 100 mgDrug
Also called SUVN-502
Tablet, Once Daily
PlaceboDrug
Matching Placebo Tablet, Once Daily
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Masupirdine Arm | Experimental | Tablet Receives: Drug: Masupirdine 50 mg |
| High Dose Masupirdine Arm | Experimental | Tablet Receives: Drug: Masupirdine 100 mg |
| Placebo | Placebo comparator | Tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen-Mansfield Agitation Inventory (CMAI)
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.
Measured: From Baseline to Week 12 visit
Secondary outcomes (1)
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)
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.
Measured: From Baseline to Week 12 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397639
- Sponsor's protocol ID
- CTP3S1502HT6
- Other IDs
- 2021-003405-22
- Status last verified
- Sep 2026
- First submitted
- 25 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No