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Atypical Antipsychotic

Brexpiprazole for Alzheimer's Disease

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose through 30 days after last dose of study drug (up to approximately week 16)
Awards & highlights

Study Summary

This study is evaluating whether a drug may help improve agitation in individuals with dementia.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose through 30 days after last dose of study drug (up to approximately week 16)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through 30 days after last dose of study drug (up to approximately week 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991
16%
Alteration in Taste
16%
Dizziness
12%
Restlessness/Akathisia
8%
Insomnia/Sleep disturbance
8%
Gastric Distress
8%
Constipation
8%
Headache
8%
Sedation
8%
Dissociation/Detachment
4%
Euphoria
4%
Nausea
4%
Elevated alt
4%
Light headedness
4%
Irritability
4%
Irregular/Early Menses
4%
Bi-lateral hand pain
4%
Shakiness
4%
Increased appetite
4%
Hot flashes
4%
Increased salivation post dose
4%
Panic episode
4%
Weight gain
4%
Lethargy
4%
Bruxism
4%
Twitching of left side lower lip
4%
Unsteadiness of gait
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prior PlaceboExperimental Treatment1 Intervention
Participants who received placebo in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received brexpiprazole following a titration schedule, to gradually increase their dose from 0.5 mg QD, in the starting to 2 or 3 mg QD, orally, for up to 12 weeks with dose adjustment.
Group II: Prior BrexpiprazoleExperimental Treatment1 Intervention
Participants who received brexpiprazole in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received the same dose of brexpiprazole [2 or 3 milligrams (mg)], once daily (QD), orally, as they received during the previous study, for up to 12 weeks with dose adjustment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
2013
Completed Phase 4
~4150

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SIndustry Sponsor
325 Previous Clinical Trials
77,324 Total Patients Enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,790 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
2018. "A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03594123.
~40 spots leftby Apr 2025
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