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NCT00417482 · ClinicalTrials.gov registry record · Phase 4
Antipsychotic Discontinuation in Alzheimer's Disease
A Phase 4 study of Alzheimer Disease and Psychotic Disorders, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 7
- Study locations
NCT00417482: Completed Phase 4 study of Alzheimer Disease and Psychotic Disorders, sponsored by New York State Psychiatric Institute.
NCT00417482 is a Phase 4 study of Alzheimer Disease and Psychotic Disorders that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 180 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00417482, a Phase 4 study of Alzheimer Disease and Psychotic Disorders, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
A relapse occurred in Phase B (post-randomization) if both of the following criteria were met: 1. Increase in the Neuropsychiatric Inventory (NPI) core score of 30% or more OR a 5-point increase from the baseline NPI score at the end of Phase A 2. A score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impression-Change (CGI-C) at any visit.
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 |
What the finished NCT00417482 record still lists
NCT00417482 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower).
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.
NCT00417482 lists 7 locations in 6 states (New York, Alabama, California).
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.
What interventions are being tested in trial NCT00417482?
The interventions under investigation include: risperidone (DRUG).
Who is sponsoring clinical trial NCT00417482?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00417482's enrollment target sits among peer trials
180 118th of 306 higher than 188 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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