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
Qualifiers
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
Treatments tested in this trial
- Masupirdine 50 mg
- Masupirdine 100 mg
- Placebo
Treatment groups
375 Participants
are divided into 3 treatment groupsLocations
44Croatia
Clinical Hospital Center Rijeka51000, Rijeka Croatia
Klinika za psihijatriju Vrapce10090, Zagreb Croatia
Polyclinic Neuron10000, Zagreb Croatia
University Hospital Center Zagreb10000, Zagreb Croatia
Sponsors and collaborators
Suven Life Sciences Limited
Lead sponsor
Source ClinicalTrials.gov