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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 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.

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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.

Conditions Studied

Alzheimer Disease Psychotic Disorders Aggression Agitation

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

FieldValue
Enrollment Target 180 participants
Start Date 2004-08
Est. Completion 2011-04
Phase Phase 4

Sponsor

New York State Psychiatric Institute

364 total trials

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What the Registry Record Tells You About NCT00417482

The ClinicalTrials.gov registry entry for NCT00417482 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.