NCT05397639 · Suven Life Sciences Limited
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
What this study is about
This study will be conducted to evaluate the effectiveness, safety, tolerability, and how the drug moves through the body of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
View original scientific description
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.
Interventions
DRUG
Masupirdine 50 mg
Tablet, Once Daily
DRUG
Masupirdine 100 mg
Tablet, Once Daily
DRUG
Placebo
Matching Placebo Tablet, Once Daily
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Anaheim, California
- Costa Mesa, California
- Encino, California
- Fresno, California
- Fullerton, California
- Los Angeles, California
- Stamford, Connecticut
- Miami, Florida
- Orlando, Florida
- Pompano Beach, Florida
- Chicago, Illinois
- Toms River, New Jersey
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations