Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's … (NCT01438060) | Clinical Trial Compass
CompletedPhase 3
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
232 participantsStarted 2000-08
Plain-language summary
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.
Who can participate
Age range
55 Years – 95 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:
* Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer
* Mini Mental State Examination (MMSE) score of 6 to 24 points
* Patients capable of self locomotion or locomotion with the aid of an assistive device
* Patients with an identified caregiver or proxy
For Extension Phase:
Eligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of ≥ 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial.
Treatment beyond 140 weeks:
All subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment
Exclusion Criteria:
* Patients with an Axis I (DSM IV) diagnosis of:
* delirium
* amnestic disorders
* bipolar disorder
* schizophrenia or schizoaffective disorder
* mood disorder with psychotic features
* Patients with reversible causes of dementia
* Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia
* Patients with psychotic symptoms that are better accounted for by another genera…
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.
What they're measuring
1
Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase
Timeframe: Baseline (Day 0), Week 10
Trial details
NCT IDNCT01438060
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.