A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
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| ClinicalTrials.gov Identifier: NCT03548584 |
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Recruitment Status :
Completed
First Posted : June 7, 2018
Results First Posted : September 18, 2023
Last Update Posted : September 18, 2023
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Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study Details
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Agitation Associated With Alzheimer's Dementia Alzheimer Dementia |
| Interventions |
Drug: Brexpiprazole Other: Placebo |
| Enrollment | 345 |
Participant Flow
| Recruitment Details | A total of 345 participants were randomized, and participated in the study from 16 May 2018 to 1 June 2022. |
| Pre-assignment Details |
| Arm/Group Title | Brexpiprazole 2 mg | Brexpiprazole 3 mg | Placebo |
|---|---|---|---|
 Arm/Group Description |
Participants followed a titration schedule, to gradually increase their dose from 0.5 milligrams per day (mg/day) in the starting to 2 mg/day from Day 15. Participants continued to receive brexpiprazole 2 milligrams (mg), once daily until Week 12. | Participants followed a titration schedule, to gradually increase their dose from 0.5 mg/day in the starting to 3 mg/day from Day 29. Participants continued to receive brexpiprazole 3 mg, once daily until Week 12. | Participants received matching placebo, once daily for 12 weeks. |
| Period Title: Overall Study | |||
| Started | 75 | 153 | 117 |
| Intent-to-treat Population [1] | 73 | 153 | 116 |
| Completed | 68 | 130 | 104 |
| Not Completed | 7 | 23 | 13 |
| Reason Not Completed | |||
| Lost to Follow-up | 0 | 0 | 1 |
| Adverse Event | 1 | 11 | 5 |
| Site Terminated by Sponsor | 1 | 3 | 2 |
| Subject Withdrew Consent to Participate | 5 | 5 | 3 |
| Lack of Efficacy | 0 | 1 | 0 |
| Non-compliance with Study Drug | 0 | 1 | 0 |
| Reason not Specified (Not Related to Coronavirus Disease 2019 [COVID-19]) | 0 | 2 | 2 |
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[1]
Intent-to-treat (ITT) Population consisted of all participants in the randomized sample, who took at least 1 dose of investigational medical product (IMP) and had a baseline and at least one post-baseline evaluation for the Cohen-Mansfield Agitation Inventory (CMAI) total score.
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Baseline Characteristics
| Arm/Group Title | Brexpiprazole 2 mg | Brexpiprazole 3 mg | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Participants followed a titration schedule, to gradually increase their dose from 0.5 mg/day in the starting to 2 mg/day from Day 15. Participants continued to receive brexpiprazole 2 mg, once daily until Week 12. | Participants followed a titration schedule, to gradually increase their dose from 0.5 mg/day in the starting to 3 mg/day from Day 29. Participants continued to receive brexpiprazole 3 mg, once daily until Week 12. | Participants received matching placebo, once daily for 12 weeks. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 75 | 153 | 117 | 345 | |
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Baseline Analysis Population Description |
Randomized Sample consisted of all participants who were randomized into this trial.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 75 participants | 153 participants | 117 participants | 345 participants | |
| 74.3 (7.3) | 74.6 (8.0) | 73.0 (7.0) | 74.0 (7.5) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 75 participants | 153 participants | 117 participants | 345 participants | |
| Female |
43 57.3%
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92 60.1%
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60 51.3%
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195 56.5%
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| Male |
32 42.7%
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61 39.9%
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57 48.7%
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150 43.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 75 participants | 153 participants | 117 participants | 345 participants | |
| Hispanic or Latino |
25 33.3%
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46 30.1%
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37 31.6%
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108 31.3%
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| Not Hispanic or Latino |
50 66.7%
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107 69.9%
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80 68.4%
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237 68.7%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 75 participants | 153 participants | 117 participants | 345 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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3 2.0%
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1 0.9%
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4 1.2%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
5 6.7%
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6 3.9%
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1 0.9%
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12 3.5%
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| White |
70 93.3%
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144 94.1%
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115 98.3%
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329 95.4%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Cohen-Mansfield Agitation Inventory (CMAI) Total Score
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
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| Number Analyzed | 75 participants | 153 participants | 117 participants | 345 participants | |
| 78.6 (15.5) | 81.2 (17.2) | 79.4 (17.6) | 80 (17) | ||
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[1]
Measure Description: The CMAI assesses frequency of agitated behaviors in elderly persons. The scale consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. Each of the agitated behaviors are scored 1 (never) to 7 (several times an hours), with the total scale score ranging from 29 to 203. Higher score indicates greater frequency of agitated behavior.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
Results Point of Contact
| Name/Title: | Director of Clinical Trials |
| Organization: | Otsuka Pharmaceutical Co., LTD. |
| Phone: | +81-3-6361-7366 |
| EMail: | CL_OPCJ_RDA_Team@otsuka.jp |
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT03548584 |
| Other Study ID Numbers: |
331-14-213 |
| First Submitted: | May 7, 2018 |
| First Posted: | June 7, 2018 |
| Results First Submitted: | May 31, 2023 |
| Results First Posted: | September 18, 2023 |
| Last Update Posted: | September 18, 2023 |