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NCT00009217 · ClinicalTrials.gov registry record · Phase 4
Treatment of Behavioral Symptoms in Alzheimer's Disease
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT00009217 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 44 participants.
The verdict
NCT00009217, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
Interventions
- DRUG Haloperidol-Haloperidol
- DRUG Haloperidol-Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 1999-01 |
| Est. Completion | 2004-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009217
The ClinicalTrials.gov registry entry for NCT00009217 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 44 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 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Haloperidol-Haloperidol is the first listed.
NCT00009217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009217 about?
NCT00009217 is a clinical study titled "Treatment of Behavioral Symptoms in Alzheimer's Disease". The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or ...
What is the current status of trial NCT00009217?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 1999-01. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00009217?
The interventions under investigation include: Haloperidol-Haloperidol (DRUG), Haloperidol-Placebo (DRUG).
Who is sponsoring clinical trial NCT00009217?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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