Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheim… (NCT02168920) | Clinical Trial Compass
TerminatedPhase 3
Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Stopped: It was difficult to secure enrollment of the targeted number of subjects.
Japan150 participantsStarted 2014-06-11
Plain-language 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
Who can participate
Age range
55 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syndro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.