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

NCT02168920 | Terminated Phase 3 DMC

• 1 other identifier: 031-13-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

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

Drug: Placebo (0 mg/day)

Interventions

2 mg/day DRUG

Once daily for 10 weeks

Aripiprazole, 2 mg/day

3 mg/day DRUG

Once daily for 10 weeks

Aripiprazole, 3 mg/day

6 mg/day DRUG

Once daily for 10 weeks

Aripiprazole, 6 mg/day

Placebo (0 mg/day) DRUG

Once daily for 10 weeks

Placebo

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:
• 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)

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

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
• Primary Completion: March 18, 2016
• Study Completion: March 18, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

JP (1)