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Treatment of Behavioral Symptoms in Alzheimer's Disease

NCT00009217 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-05-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Haloperidol-Haloperidol

Haloperidol open label flexible dose 1-5 mg daily for 20 weeks followed by haloperidol double-blind 1-5 mg for 24 weeks

DRUG

Haloperidol-Placebo

Haloperidol open-label flexible dose of 1-5 mg for 20 weeks followed by placebo double-blind for 24 weeks

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Davangere Devanand, M.D. · Columbia University College of Physicians and Surgeon

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
1999-01-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00009217 on ClinicalTrials.gov