Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014