Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00034762
First received: May 2, 2002
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to evaluate the efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with Alzheimer's disease


Condition Intervention Phase
Dementia
Alzheimer Disease
Mental Disorders
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of A Flexible Dose Of Risperidone Versus Placebo In The Treatment Of Psychosis Of Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline to end of treatment (Week 8) in Psychosis Cluster Score of Pathology from the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Rating Scale and Clinical Global Impression (CGI).

Secondary Outcome Measures:
  • Change in BEHAVE-AD total score and subscales (other than Psychosis Cluster subscale) from baseline; improvement in CGI scores during treatment; incidence of adverse events throughout study.

Enrollment: 473
Study Start Date: December 2000
Study Completion Date: January 2003
Detailed Description:

Dementia is frequently observed in the elderly, often associated with psychotic symptoms such as delusion or hallucinations, or with behavioral disturbances such as aggressive behavior, wandering, and aimless behavior induced by the psychotic symptoms. This is a double-blind, placebo-controlled study of the effectiveness and safety of risperidone (taken twice daily over 8 weeks) in the treatment of psychotic symptoms in patients with Alzheimer's disease. Assessments of effectiveness include: Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD), a scale used for global assessment of symptoms associated with dementia; the Psychosis Cluster Scale of BEHAVE-AD, a subscale that assesses paranoid and delusional ideation as well as hallucination; and Clinical Global Impression-Change (CGI-C), a measure of an improved or aggravated condition. Safety evaluations include the incidence of adverse events throughout the study; physical examinations, electrocardiograms (ECGs), laboratory tests (hematology, biochemistry, urinalysis), and assessment of extrapyramidal symptoms at specified intervals. The study hypothesis is that treatment with risperidone shows greater improvement in psychotic symptoms, as measured by the BEHAVE-AD psychotic cluster score, in patients with Alzheimer's disease, as compared to placebo. In addition, it is hypothesized that risperidone is well tolerated. Risperidone tablets (0.25 mg or 0.50 mg) or placebo tablets taken orally twice daily. Total daily dosage of 0.5mg on Day 1, 1.0mg on Days 3-5, and 1.5mg (maximum dose) on Days 5-13. Optimum dose maintained during Weeks 3-8 of treatment.Dose may be increased or decreased at investigator's discretion.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of dementia of the Alzheimer's type with or without a vascular component, a score of 2 or more on any item of the BEHAVE-AD psychosis subscale at screening, and a Mini-Mental State Examination (MMSE) score of 5 to 23
  • Residents of nursing homes or long-term care facilities and deemed in need of treatment with an atypical antipsychotic medication.

Exclusion Criteria:

  • Disease that could significantly diminish cognitive function
  • history of neuroleptic malignant syndrome
  • hypersensitivity to risperidone.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034762

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00034762     History of Changes
Other Study ID Numbers: CR002764
Study First Received: May 2, 2002
Last Updated: January 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Alzheimer's disease
psychosis
elderly
dementia
risperidone
antipsychotic agents

Additional relevant MeSH terms:
Alzheimer Disease
Mental Disorders
Psychotic Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014