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| Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00034762 |
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 |
|---|---|---|
|
Alzheimer Disease Mental Disorders Dementia |
Drug: risperidone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy And Safety Of A Flexible Dose Of Risperidone Versus Placebo In The Treatment Of Psychosis Of Alzheimer's Disease. |
| Estimated Enrollment: | 460 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | January 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR002764 |
| Study First Received: | May 2, 2002 |
| Last Updated: | April 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00034762 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
antipsychotic agents elderly psychosis |
dementia risperidone Alzheimer's disease |
|
Neurotransmitter Agents Tranquilizing Agents Alzheimer Disease Psychotropic Drugs Risperidone Central Nervous System Depressants Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Antipsychotic Agents |
Cognition Disorders Serotonin Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dopamine Agents Psychotic Disorders Dementia Delirium |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Psychotropic Drugs Risperidone Central Nervous System Depressants Central Nervous System Diseases Dopamine Antagonists Antipsychotic Agents |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Serotonin Antagonists Delirium, Dementia, Amnestic, Cognitive Disorders Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Dementia Tauopathies Central Nervous System Agents |