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A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

NCT03548584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2023-09-18

Study results available
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Summary

This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

Conditions

  • Agitation Associated With Alzheimer's Dementia
  • Alzheimer Dementia

Interventions

DRUG

Brexpiprazole

Oral tablets

OTHER

Placebo

Oral tablets

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2022-05-23
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03548584 on ClinicalTrials.gov