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Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Primary Purpose

Agitation Associated With Dementia of the Alzheimer's Type

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
2 mg/day
3 mg/day
6 mg/day
Placebo (0 mg/day)
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation Associated With Dementia of the Alzheimer's Type focused on measuring Alzeheimer

Eligibility Criteria

55 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).

  • Patients who satisfy both of the following diagnostic criteria:

    • Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5)
    • Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
  • Hospitalized patients or care facility patients
  • Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22

Exclusion Criteria:

  • Patients with complications of dementia or memory impairment other than Alzheimer's type dementia
  • Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher
  • Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances
  • Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke
  • Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV
  • Patients who require drug therapy for arrhythmia or ischemic heart disease
  • Body weight of less than 30 kg
  • Patients with a high risk of suicide
  • Patients with a complication or history of seizure disorder
  • Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis
  • Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Aripiprazole, 2 mg/day

Aripiprazole, 3 mg/day

Aripiprazole, 6 mg/day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

CMAI
Change from baseline

Secondary Outcome Measures

Clinical Global Impression of Severity （CGI-S）
Change from baseline
Clinical Global Impression-Improvement (CGI-I)
Score after 10 weeks

Full Information

First Posted
June 18, 2014
Last Updated
October 13, 2017
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02168920
Brief Title
Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
It was difficult to secure enrollment of the targeted number of subjects.
Study Start Date
June 11, 2014 (Actual)
Primary Completion Date
March 18, 2016 (Actual)
Study Completion Date
March 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia
Detailed Description
This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparison trial to assess the efficacy and safety of aripiprazole in patients with agitation associated with Alzheimer's type dementia. Screening period is 4 weeks. Patients are randomly assigned to one of 4 groups, and treatment period is 10 weeks. Period of post-treatment observation is 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation Associated With Dementia of the Alzheimer's Type
Keywords
Alzeheimer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole, 2 mg/day
Arm Type
Experimental
Arm Title
Aripiprazole, 3 mg/day
Arm Type
Experimental
Arm Title
Aripiprazole, 6 mg/day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
2 mg/day
Intervention Description
Once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
3 mg/day
Intervention Description
Once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
6 mg/day
Intervention Description
Once daily for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (0 mg/day)
Intervention Description
Once daily for 10 weeks
Primary Outcome Measure Information:
Title
CMAI
Description
Change from baseline
Time Frame
Baseline, 10 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Severity （CGI-S）
Description
Change from baseline
Time Frame
Baseline, 10 weeks
Title
Clinical Global Impression-Improvement (CGI-I)
Description
Score after 10 weeks
Time Frame
10 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible). Patients who satisfy both of the following diagnostic criteria: Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5) Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Hospitalized patients or care facility patients Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22 Exclusion Criteria: Patients with complications of dementia or memory impairment other than Alzheimer's type dementia Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV Patients who require drug therapy for arrhythmia or ischemic heart disease Body weight of less than 30 kg Patients with a high risk of suicide Patients with a complication or history of seizure disorder Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)
Facility Information:
City
Kanto Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

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