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

NCT ID: NCT02168920

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-11

Study Completion Date

2016-03-18

Brief Summary

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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

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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.

Conditions

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Agitation Associated With Dementia of the Alzheimer's Type

Keywords

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Alzeheimer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aripiprazole, 2 mg/day

Group Type EXPERIMENTAL

2 mg/day

Intervention Type DRUG

Once daily for 10 weeks

Aripiprazole, 3 mg/day

Group Type EXPERIMENTAL

3 mg/day

Intervention Type DRUG

Once daily for 10 weeks

Aripiprazole, 6 mg/day

Group Type EXPERIMENTAL

6 mg/day

Intervention Type DRUG

Once daily for 10 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (0 mg/day)

Intervention Type DRUG

Once daily for 10 weeks

Interventions

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2 mg/day

Once daily for 10 weeks

Intervention Type DRUG

3 mg/day

Once daily for 10 weeks

Intervention Type DRUG

6 mg/day

Once daily for 10 weeks

Intervention Type DRUG

Placebo (0 mg/day)

Once daily for 10 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanto Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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031-13-001

Identifier Type: -

Identifier Source: org_study_id