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Sponsored by: |
Janssen Pharmaceutical K.K. |
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Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00287742 |
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 | Intervention | Phase |
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Alzheimer's Disease Dementia |
Drug: risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Placebo-Controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease |
Estimated Enrollment: | 296 |
Study Completion Date: | March 2003 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003172 |
Study First Received: | February 3, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00287742 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
psychosis dementia risperidone Alzheimer's disease antipsychotic agents |
Neurotransmitter Agents Hallucinations Psychotropic Drugs Neurodegenerative Diseases Brain Diseases Signs and Symptoms Delusions Dopamine Mental Disorders Psychotic Disorders Dementia Neurobehavioral Manifestations Delirium |
Tranquilizing Agents Alzheimer Disease Risperidone Central Nervous System Diseases Central Nervous System Depressants Antipsychotic Agents Cognition Disorders Serotonin Delirium, Dementia, Amnestic, Cognitive Disorders Neurologic Manifestations Dopamine Agents Perceptual Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hallucinations Physiological Effects of Drugs Psychotropic Drugs Neurodegenerative Diseases Brain Diseases Signs and Symptoms Serotonin Antagonists Mental Disorders Therapeutic Uses Dementia Neurobehavioral Manifestations Tranquilizing Agents Nervous System Diseases |
Alzheimer Disease Risperidone Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Serotonin Agents Neurologic Manifestations Dopamine Agents Tauopathies Central Nervous System Agents Perceptual Disorders |