CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
risperidonedrug
Likely dose
risperidone 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00417482
NCT00417482Phase 4Completed
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Antipsychotic Discontinuation in Alzheimer's Disease

New York State Psychiatric Institute·interventional·Posted Jan 1, 2007·Updated Apr 24, 2013

In Brief

A Phase 4 clinical trial evaluating risperidone for Alzheimer Disease and 3 related conditions. Completed, enrolled 180 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease, Psychotic Disorders, Agitation, Aggression
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), Columbia University

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 1, 2007
Enrollment StartAug 1, 2004
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 19.5 years ago

Interventions

risperidonedrug

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