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

This study has been terminated.
(A decision was made to discontinue the study due to a change in the strategic direction of the company.)
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00287742
First received: February 3, 2006
Last updated: May 20, 2011
Last verified: November 2010
  Purpose

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
Alzheimer's Disease
Dementia
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 33
Study Start Date: March 2002
Study Completion Date: March 2003
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287742

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00287742     History of Changes
Other Study ID Numbers: CR003172
Study First Received: February 3, 2006
Last Updated: May 20, 2011
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
risperidone
antipsychotic agents
Alzheimer's disease
dementia
psychosis

Additional relevant MeSH terms:
Alzheimer Disease
Delusions
Dementia
Hallucinations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists

ClinicalTrials.gov processed this record on August 28, 2014