Agitation, Alzheimer's Type Dementia
Conditions
Keywords
Masupirdine, SUVN-502, Phase 3, Agitation
Brief 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.
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.
Interventions
DRUGMasupirdine 50 mg
Tablet, Once Daily
DRUGMasupirdine 100 mg
Tablet, Once Daily
DRUGPlacebo
Matching Placebo Tablet, Once Daily
Sponsors
Suven Life Sciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) | 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. |
Countries
Croatia, Poland, Serbia, United States
Outcome results
None listed