Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-90
SponsorSuven Life Sciences Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Masupirdine 50 mg
DrugTablet, Once Daily
Masupirdine 100 mg
DrugTablet, Once Daily
Placebo
DrugMatching Placebo Tablet, Once Daily
Treatment groups
375 Participants
are divided into 3 treatment groupsGroup A: Low Dose Masupirdine ArmExperimental treatment 1 intervention
Group B: High Dose Masupirdine ArmExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Baseline to Week 12 visitSecondary 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.
Time frame
From Baseline to Week 12 visitSponsors and contacts
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Source ClinicalTrials.gov