NCT02168920

TerminatedPhase 3

Aripiprazole for the Treatment of Patients With Agitation As...

Otsuka Pharmaceutical Co., Ltd.Source

Otsuka Pharmaceutical Co., Ltd.ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

031-13-001

Study Type

interventional

Actual enrollment (reported)

150

Locations

1 country

Sites

1

Timeline

Study Start

June 11, 2014

Actual (reported)

Primary Completion

March 18, 2016

Actual (reported)

Study Completion

March 18, 2016

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 150 participants
Study completion date: March 18, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 11, 2014
Actual (reported)
First Submitted
June 18, 2014
Actual (reported)
First Posted
June 20, 2014
Actual (reported)
Primary Completion
March 18, 2016
Actual (reported)
Study Completion
March 18, 2016
Actual (reported)

Last Updated: October 16, 2017
Status Verified: October 2017
Last Update Submitted: October 13, 2017

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Keywords

Alzeheimer

Outcome Measures

Primary Outcomes (1)

CMAI
Change from baseline
Baseline, 10 weeks

Secondary Outcomes (2)

Clinical Global Impression of Severity （CGI-S）
Baseline, 10 weeks
Clinical Global Impression-Improvement (CGI-I)
10 Weeks

Study Arms (4)

Aripiprazole, 2 mg/day

EXPERIMENTAL

Drug: 2 mg/day

Aripiprazole, 3 mg/day

EXPERIMENTAL

Drug: 3 mg/day

Aripiprazole, 6 mg/day

EXPERIMENTAL

Drug: 6 mg/day

Placebo

PLACEBO COMPARATOR

Interventions

2 mg/dayDrug

Once daily for 10 weeks

Aripiprazole, 2 mg/day

3 mg/dayDrug

Once daily for 10 weeks

Aripiprazole, 3 mg/day

Eligibility Criteria

Age55 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).
Patients who satisfy both of the following diagnostic criteria:

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Kanto Region, Japan

Enrollment

150 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

June 11, 2014

Actual (reported)

Drug: Placebo (0 mg/day)

6 mg/dayDrug

Once daily for 10 weeks

Aripiprazole, 6 mg/day

Placebo (0 mg/day)Drug

Once daily for 10 weeks

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

March 18, 2016

Actual (reported)

Study Completion

March 18, 2016

Actual (reported)

Last Updated

October 16, 2017

Record last verified: 2017-10

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02168920
Data provider: ClinicalTrials.gov
Source updated: 2017-10-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:40 UTC

Locations

JP(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Aripiprazole, 2 mg/day

Aripiprazole, 3 mg/day

Aripiprazole, 6 mg/day

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Aripiprazole, 2 mg/day

Aripiprazole, 3 mg/day

Aripiprazole, 6 mg/day

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations