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

NCT05397639 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Agitation
  • Alzheimer's Type Dementia

Interventions

DRUG

Masupirdine 50 mg

Tablet, Once Daily

DRUG

Masupirdine 100 mg

Tablet, Once Daily

DRUG

Placebo

Matching Placebo Tablet, Once Daily

Sponsors & Collaborators

  • Suven Life Sciences Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Croatia
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397639 on ClinicalTrials.gov