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Antipsychotic Discontinuation in Alzheimer's Disease

NCT00417482 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-04-24

Study results available
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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

  • Alzheimer Disease
  • Psychotic Disorders
  • Agitation
  • Aggression

Interventions

DRUG

risperidone

Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Columbia University

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Davangere P. Devanand, MD · NYSPI/Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417482 on ClinicalTrials.gov