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 range55 Years – 95 Years
SexALL
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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…
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.