Agitation Associated With Dementia of the Alzheimer's TypePhase 3NCT02168920
Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
A Phase 3 study testing 2 mg/day, 3 mg/day and 6 mg/day in people with Agitation Associated With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Agitation Associated With Dementia of the Alzheimer's Type
- What is being tested?
- 2 mg/day, 3 mg/day and 6 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- 11 Jun 2014to 18 Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- 2 mg/day, 3 mg/day, 6 mg/day, Placebo (0 mg/day)
- Keywords
- Alzeheimer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg/dayDrug
Once daily for 10 weeks
3 mg/dayDrug
Once daily for 10 weeks
6 mg/dayDrug
Once daily for 10 weeks
Placebo (0 mg/day)Drug
Once daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole, 2 mg/day | Experimental | Not described Receives: Drug: 2 mg/day |
| Aripiprazole, 3 mg/day | Experimental | Not described Receives: Drug: 3 mg/day |
| Aripiprazole, 6 mg/day | Experimental | Not described Receives: Drug: 6 mg/day |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (0 mg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMAI
Change from baseline
Measured: Baseline, 10 weeks
Secondary outcomes (2)
Clinical Global Impression of Severity （CGI-S）
Change from baseline
Measured: Baseline, 10 weeks
Clinical Global Impression-Improvement (CGI-I)
Score after 10 weeks
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study start11 Jun 2014
- Primary completion18 Mar 2016
- Study completion18 Mar 2016
Why it stopped: It was difficult to secure enrollment of the targeted number of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation Associated With Dementia of the Alzheimer's TypeStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168920
- Sponsor's protocol ID
- 031-13-001
- Status last verified
- Oct 2017
- First submitted
- 18 Jun 2014
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02168920
- Acronym / sponsor ID
- 031-13-001
- Keywords
- Alzeheimer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was difficult to secure enrollment of the targeted number of subjects.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 18 Mar 2016 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).
- Patients who satisfy both of the following diagnostic criteria:
- Hospitalized patients or care facility patients
- Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 mg/dayOnce daily for 10 weeks | Drug | Aripiprazole, 2 mg/day |
| 3 mg/dayOnce daily for 10 weeks | Drug | Aripiprazole, 3 mg/day |
| 6 mg/dayOnce daily for 10 weeks | Drug | Aripiprazole, 6 mg/day |
| Placebo (0 mg/day)Once daily for 10 weeks | Drug | Placebo |
Primary outcome
CMAI
Time frame: Baseline, 10 weeks
Change from baseline
2 secondary outcomes
Clinical Global Impression of Severity （CGI-S）
Time frame: Baseline, 10 weeks
Clinical Global Impression-Improvement (CGI-I)
Time frame: 10 Weeks
Results and safety
The study was stopped early (reason given: It was difficult to secure enrollment of the targeted number of subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2 mg/day, 3 mg/day and 6 mg/day in people with Agitation Associated With Dementia of the Alzheimer's Type, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was difficult to secure enrollment of the targeted number of subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMAI (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.