A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Behavioral Disturbances in Patients With Dementia
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ClinicalTrials.gov Identifier: NCT00253123 |
Recruitment Status :
Completed
First Posted : November 15, 2005
Last Update Posted : December 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia Alzheimer Disease Dementia, Vascular | Drug: risperidone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 626 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone for Treatment of Behavioral Disturbances in Subjects With Dementia |
Actual Study Completion Date : | March 1997 |

- Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.
- Change from baseline to the end of double-blind treatment in BEHAVE-AD global rating and total score; total CMAI score; CGI and CGI change from baseline; PSMS; safety evaluations conducted throughout the study.

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a diagnosis of dementia of the Alzheimer's type, mixed dementia, or vascular dementia, as classified by the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- a score of 4 or more on the Functional Assessment Staging (FAST), a diagnostic tool for determining the stage of dementia
- a score of 23 or lower on the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition
- a BEHAVE-AD total score of at least 8, and a BEHAVE-AD global rating of at least 1
- residence in a psychiatric hospital, nursing home, or other long-term care facility for at least 1 month.
Exclusion Criteria:
- Patients with untreated, reversible causes of dementia
- with general medical or neurological conditions in which cognition is diminished (for example, untreated vitamin deficiency, severe liver or kidney malfunctions, brain tumor, etc.)
- with dementia related to HIV infection (human immunodeficiency virus)
- with a substance-induced persisting dementia
- with psychiatric disorders that could account for the behavior disturbances, such as schizophrenia.

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): NCT00253123
Study Director: | Janssen, LP Clinical Trial | Janssen, LP |
ClinicalTrials.gov Identifier: | NCT00253123 |
Other Study ID Numbers: |
CR006022 |
First Posted: | November 15, 2005 Key Record Dates |
Last Update Posted: | December 3, 2010 |
Last Verified: | December 2010 |
Dementia Alzheimer's disease vascular dementia |
mixed dementia risperidone nursing home |
Alzheimer Disease Dementia Dementia, Vascular Problem Behavior Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases 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 |