- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287742
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
May 20, 2011 updated by: Janssen Pharmaceutical K.K.
Double-blind, Placebo-controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion (ACTUAL)
March 1, 2003
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 3, 2006
First Posted (ESTIMATE)
February 7, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
May 24, 2011
Last Update Submitted That Met QC Criteria
May 20, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Perceptual Disorders
- Dementia
- Alzheimer Disease
- Hallucinations
- Delusions
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR003172
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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