Antipsychotic Discontinuation in Alzheimer's Disease (ADAD)
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ClinicalTrials.gov Identifier: NCT00417482 |
Recruitment Status
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Completed
First Posted
: January 1, 2007
Results First Posted
: April 24, 2013
Last Update Posted
: April 24, 2013
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Sponsor:
New York State Psychiatric Institute
Collaborators:
National Institute on Aging (NIA)
Columbia University
Information provided by (Responsible Party):
New York State Psychiatric Institute
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Tracking Information | ||||
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First Submitted Date ICMJE | December 28, 2006 | |||
First Posted Date ICMJE | January 1, 2007 | |||
Results First Submitted Date | February 11, 2013 | |||
Results First Posted Date | April 24, 2013 | |||
Last Update Posted Date | April 24, 2013 | |||
Study Start Date ICMJE | August 2004 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Relapse by Study Week 32 [ Time Frame: 0-16 weeks in Phase B (16-32 weeks in study) ] A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00417482 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Antipsychotic Discontinuation in Alzheimer's Disease | |||
Official Title ICMJE | Antipsychotic Discontinuation in Alzheimer's Disease | |||
Brief Summary | In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation. | |||
Detailed Description | This multicenter study (6 academic sites and 2 non-academic sites) involves treating AD patients (assisted living or nursing home patients, and outpatients) using an atypical antipsychotic, risperidone. In Phase A, 180 AD patients with psychosis and/or agitation/aggression receive open treatment with risperidone for 16 weeks. Responders are randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for the next 32 weeks, (2) risperidone for the next 16 weeks followed by placebo for 16 weeks, or (3) placebo for the next 32 weeks. The primary hypothesis is that in the first 16 weeks of Phase B, relapse risk will be lower with continuation risperidone (Arms 1 + 2) compared to discontinuation on placebo (Arm 3). The secondary hypothesis is that in the second 16 weeks of Phase B, relapse risk will be lower with continuation risperidone (Arm 1) compared to discontinuation on placebo (Arm 2). For both randomized time periods, the proportions who relapse will be compared for interpretive support. This design provides useful data on the efficacy and side effects of longer term treatment with risperidone, and, in particular, critical information about the time to relapse and likelihood of relapse in patients switched from risperidone to placebo. This information is essential to guide the clinician toward optimal use of such medications in one of the most challenging types of patients: the AD patient with psychosis and/or agitation/aggression. The results of this study will also help to address Federal regulations urging early antipsychotic discontinuation in nursing homes. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: risperidone
Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial
Other Name: Risperdal |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
180 | |||
Original Enrollment ICMJE |
200 | |||
Actual Study Completion Date | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 95 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00417482 | |||
Other Study ID Numbers ICMJE | #5598R 5R01AG021488 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | New York State Psychiatric Institute | |||
Study Sponsor ICMJE | New York State Psychiatric Institute | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | New York State Psychiatric Institute | |||
Verification Date | March 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |