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Antipsychotic Discontinuation in Alzheimer's Disease
NCT00417482 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG risperidone
Study Locations (7)
New York
- Mount Sinai School of Medicine, Alzheimer's Disease Research Center — New York
- New York State Psychiatric Institute, Columbia University — New York
Alabama
- Tuscaloosa VA Medical Center, Department of Psychiatry — Tuscaloosa
California
- WLA VA Medical Center/UCLA, Psychiatry — Los Angeles
Connecticut
- Research Center for Clinical Studies, Inc. — Norwalk
Iowa
- University of Iowa College of Medicine — Iowa City
South Carolina
- Medical University of South Carolina — North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2004-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00417482
The ClinicalTrials.gov registry entry for NCT00417482 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention — of which risperidone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00417482 reports 7 study locations spanning 6 distinct geographic areas — top geographies include New York, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00417482 about?
NCT00417482 is a clinical study titled "Antipsychotic Discontinuation in Alzheimer's Disease". 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). Respo...
What is the current status of trial NCT00417482?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2004-08. Estimated completion is 2011-04.
What conditions does trial NCT00417482 study?
This clinical trial studies the following conditions: Alzheimer Disease, Psychotic Disorders, Aggression, Agitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00417482?
The interventions under investigation include: risperidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00417482?
This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00417482 being conducted?
This trial has 7 study locations across Alabama, California, Connecticut, Iowa, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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