Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Masupirdine 50 mg, Masupirdine 100 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Agitation, Alzheimer's Type Dementia. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Croatia, Poland, Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Overview
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
- 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]
Secondary outcome measures (1)
- Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) [Time frame: From Baseline to Week 12 visit]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 27 centers
- Advanced Research Center, Inc. — Anaheim
- ATP Clinical Research, Inc. — Costa Mesa
- Leading Edge Research LA, LLC — Encino
- Neuro Pain Medical Center — Fresno
- Neurology Center of North Orange County — Fullerton
- Mary S Easton Center for Alzheimer's Research and Care UCLA — Los Angeles
- Ki Health Partners, LLC — Stamford
- Allied Biomedical Research Institute — Miami
- … and 19 more centers
Poland · 8 centers
- Medycyna Milorzab sp. z o.o. — Lodz
- FutureMeds Warszawa Centrum — Warsaw
- MTZ Clinical Research powered by Pratia — Warsaw
- Centrum Leczenia Zaburzen Pamieci Affidea — Warsaw
- Centrum Medyczne Silmedic Sp z o o — Katowice
- EMC Silesia Sp. z o.o. — Katowice
- Neuro-Medic Janusz Zbrojkiewicz — Katowice
- ClinHouse Centrum Medyczne — Zabrze
Serbia · 5 centers
- Clinical Hospital Center Dragisa Misovic Dedinje — Belgrade
- Special Hospital for Psychiatric Diseases — Kovin
- University Clinical Center Kragujevac, Clinic for Psychiatry — Kragujevac
- University Clinical Center Nis, Clinic for neurology — Niš
- Clinical Centre of Vojvodina, Clinic of Neurology — Novi Sad
Croatia · 4 centers
- Clinical Hospital Center Rijeka — Rijeka
- Polyclinic Neuron — Zagreb
- University Hospital Center Zagreb — Zagreb
- Klinika za psihijatriju Vrapce — Zagreb
Identifiers
NCT: NCT05397639 · CTP3S1502HT6 · 2021-003405-22