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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.

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

Condition or disease Intervention/treatment Phase
Agitation Associated With Dementia of the Alzheimer's Type Drug: 2 mg/day Drug: 3 mg/day Drug: 6 mg/day Drug: Placebo (0 mg/day) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2014
Actual Primary Completion Date : March 18, 2016
Actual Study Completion Date : March 18, 2016


Arm Intervention/treatment
Experimental: Aripiprazole, 2 mg/day Drug: 2 mg/day
Once daily for 10 weeks

Experimental: Aripiprazole, 3 mg/day Drug: 3 mg/day
Once daily for 10 weeks

Experimental: Aripiprazole, 6 mg/day Drug: 6 mg/day
Once daily for 10 weeks

Placebo Comparator: Placebo Drug: Placebo (0 mg/day)
Once daily for 10 weeks




Primary Outcome Measures :
  1. CMAI [ Time Frame: Baseline, 10 weeks ]
    Change from baseline


Secondary Outcome Measures :
  1. Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, 10 weeks ]
    Change from baseline

  2. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 10 Weeks ]
    Score after 10 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168920


Locations
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Japan
Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02168920    
Other Study ID Numbers: 031-13-001
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Alzeheimer
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations