Antipsychotic Discontinuation in Alzheimer's Disease
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
Columbia University National Institute on Aging (NIA)