This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Sponsored by Suven Life Sciences Limited

About this trial

Last updated 2 years ago

Study ID

CTP3S1502HT6

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
50 to 90 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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).

No

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting