Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Recruiting
Phase 3Interventional Study
AgitationAlzheimer's Type Dementia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
375 (estimated)
Sponsor
Suven Life Sciences Limited · Industry
Who this trial is looking for
This trial is looking for people with Alzheimer's dementia who have confirmed agitation. Participants will receive either the study drug masupirdine or a placebo to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Alzheimer's type dementia
I have confirmed agitation
I have a score between 8 and 24 on the Mini-Mental State Examination
You may not be able to join if
I have dementia that is not primarily of the Alzheimer's type
My agitation is caused by something other than Alzheimer's disease
I am considered ineligible by the investigator
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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