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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168920
Recruitment Status : Terminated (It was difficult to secure enrollment of the targeted number of subjects.)
First Posted : June 20, 2014
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date October 16, 2017
Actual Study Start Date  ICMJE June 11, 2014
Actual Primary Completion Date March 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
CMAI [ Time Frame: Baseline, 10 weeks ]
Change from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, 10 weeks ]
    Change from baseline
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 10 Weeks ]
    Score after 10 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation Associated With Dementia of the Alzheimer's Type
Intervention  ICMJE
  • Drug: 2 mg/day
    Once daily for 10 weeks
  • Drug: 3 mg/day
    Once daily for 10 weeks
  • Drug: 6 mg/day
    Once daily for 10 weeks
  • Drug: Placebo (0 mg/day)
    Once daily for 10 weeks
Study Arms  ICMJE
  • Experimental: Aripiprazole, 2 mg/day
    Intervention: Drug: 2 mg/day
  • Experimental: Aripiprazole, 3 mg/day
    Intervention: Drug: 3 mg/day
  • Experimental: Aripiprazole, 6 mg/day
    Intervention: Drug: 6 mg/day
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (0 mg/day)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2017)
150
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
880
Actual Study Completion Date  ICMJE March 18, 2016
Actual Primary Completion Date March 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168920
Other Study ID Numbers  ICMJE 031-13-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP