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Masupirdine for Agitation in Alzheimer's Type Dementia

This study is testing Masupirdine, a tablet taken once daily, to see if it can help reduce agitation in people with Alzheimer's type dementia. You could receive either Masupirdine at 50 mg or 100 mg, or a placebo (an inactive pill that looks the same). The study aims to see how well Masupirdine works, if it's safe, and how your body handles it. To join, you need to be between 50 and 90 years old, have a diagnosis of Alzheimer's type dementia, and experience agitation. Success will be measured by changes in agitation levels over 12 weeks. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving about 375 participants across 50 centers worldwide. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would take study medication orally once daily for 12 weeks (85 days). There will be a screening period of about 4 weeks before you are assigned to a treatment group.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of success is taken from the start of the study until the 12-week visit.

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NCT05397639

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

Recruiting
PHASE3Ages 50–90InterventionalTreatment
Suven Life Sciences Limited
~375 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:Masupirdine 50 mgMasupirdine 100 mgPlacebo

At a glance

Recruiting sites
44 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohen-Mansfield Agitation Inventory (CMAI)
Measured over From Baseline to Week 12 visit

Conditions

Agitation
Alzheimer's Type Dementia

Explore related trials

Alzheimer's Disease

Where it's being run

44 sites across 15 states
Florida8
California6
Serbia5
Texas4
Croatia4
Masovian Voivodeship3
Silesian Voivodeship3
Illinois2

Who to contact

Study Contact
[email protected]
+9140 2319 3956
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Cohen-Mansfield Agitation Inventory (CMAI)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.