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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: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00009217 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00009217 record still lists
NCT00009217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Haloperidol-Haloperidol is the first listed.
NCT00009217 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00009217's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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