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A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287742
Recruitment Status : Terminated (A decision was made to discontinue the study due to a change in the strategic direction of the company.)
First Posted : February 7, 2006
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.

Study Description
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Brief Summary:
The purpose of this study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo for the treatment of patients with hallucinations and delusions associated with Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Drug: risperidone Phase 3

Detailed Description:
Dementia is frequently observed in the elderly, often associated with psychotic symptoms such as delusion or hallucination, or with behavioral disturbances such as aggressive behavior, wandering, and aimless behavior induced by the psychotic symptoms. Based on the results of preliminary clinical studies, risperidone can be expected to be beneficial for the treatment of psychotic symptoms and behavioral disturbances associated with Alzheimer's disease. This is a multicenter, randomized, double-blind, placebo-controlled study of risperidone tablets or placebo tablets taken twice daily over 9 weeks by patients with hallucinations and delusions associated with Alzheimer's disease. During the one week run-in period, patients take one tablet twice daily. During the 8 week double-blind period, the dose is given twice daily in a flexible dose regimen of 0.5 to 2 mg of risperidone per day, or placebo. The primary measure of effectiveness is the change in Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic symptom cluster score from baseline and intermediate visits to study end (Week 9) compared with placebo. BEHAVE-AD is a scale used for global assessment of symptoms associated with dementia. Additional assessments of effectiveness include the Cohen-Mansfield Agitation Inventory (CMAI), an assessment of aggressiveness and non-aggressiveness, and the Clinical Global Impression - Change (CGI-C), a measure of an improved or aggravated condition. Safety evaluations include the incidence of adverse events, physical examinations, electrocardiograms (ECGs), laboratory tests (biochemistry, hematology, and urinalysis), and assessment of extrapyramidal symptoms. The study hypothesis is that treatment twice daily with risperidone is more effective than placebo on measures of the BEHAVE-AD psychotic symptom cluster score in patients with hallucinations and delusions associated with Alzheimer's disease. Oral risperidone tablets 0.25 mg or placebo tablets twice daily, increasing in weekly increments of 0.5 mg/day to a maximum of 2 mg/day; total daily dosage will be maintained for 9 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease
Study Start Date : March 2002
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic symptom cluster score from baseline and intermediate visits to study end (Week 9) compared with placebo.

Secondary Outcome Measures :
  1. Changes in BEHAVE-AD total, subscales and items scores, changes in CMAI aggressiveness and non-aggressiveness item scores and changes in CGI-C from baseline and intermediate visits to study end (Week 9) compared with placebo. Safety evaluations.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's disease according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
  • Mini-Mental State Examination (MMSE) score of not greater than 23
  • Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic score of >=2 for any item in the psychotic cluster
  • occurrence of hallucination or delusion after onset of symptoms of dementia at least 28 days before screening.

Exclusion Criteria:

  • Patients with a disease that could significantly diminish cognitive function (e.g., Parkinsonism, Huntington's disease, Creutzfeldt-Jacob disease, dementia of Levy body type, vitamin B12 or folic acid deficiency)
  • persistent dementia or amnestic disorders according to DSM-IV criteria
  • occurrence of hallucination or delusion only while delirium is observed
  • psychiatric symptoms induced by psychosis (e.g., schizophrenia, schizoaffective disorders, delusional disorders, depression or bipolar disorders)
  • history of neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287742


Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00287742    
Other Study ID Numbers: CR003172
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: November 2010
Keywords provided by Janssen Pharmaceutical K.K.:
risperidone
antipsychotic agents
Alzheimer's disease
dementia
psychosis
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Hallucinations
Delusions
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Behavioral Symptoms
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents