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TerminatedNCT02168920Updated Oct 16, 2017

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

A Phase 3 interventional study of 2 mg/day and 3 mg/day in Agitation Associated With Dementia of the Alzheimer's Type, sponsored by Otsuka Pharmaceutical Co., Ltd.. Terminated at 1 site in Japan. Open to participants aged 55 Years to 89 Years. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
It was difficult to secure enrollment of the targeted number of subjects.
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
55 Years to 89 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Agitation Associated With Dementia of the Alzheimer's Type

Keywords

  • Alzeheimer
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 150 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Aripiprazole, 2 mg/day

    Drug: 2 mg/day

  • Experimental
    Aripiprazole, 3 mg/day

    Drug: 3 mg/day

  • Experimental
    Aripiprazole, 6 mg/day

    Drug: 6 mg/day

  • Placebo comparator
    Placebo

    Drug: Placebo (0 mg/day)

Interventions

  • Drug2 mg/day

    Once daily for 10 weeks

  • Drug3 mg/day

    Once daily for 10 weeks

  • Drug6 mg/day

    Once daily for 10 weeks

  • DrugPlacebo (0 mg/day)

    Once daily for 10 weeks

06

What researchers measure

Primary outcomes

  1. CMAI

    Change from baseline

    Time frame: Baseline, 10 weeks

Secondary outcomes

  1. Clinical Global Impression of Severity （CGI-S）

    Change from baseline

    Time frame: Baseline, 10 weeks

  2. Clinical Global Impression-Improvement (CGI-I)

    Score after 10 weeks

    Time frame: 10 Weeks

07

Study locations

1 site
  • Kanto Region, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02168920
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 20, 2014
Start date
Jun 11, 2014
Primary completion
Mar 18, 2016
Completion
Mar 18, 2016
Last update
Oct 16, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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