Treatment of Behavioral Symptoms in Alzheimer's Disease
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
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.