Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimer's Disease

NCT ID: NCT00034762

Last Updated: 2011-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2003-01-31

Brief Summary

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

Detailed Description

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.

Conditions

Dementia; Alzheimer Disease; Mental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

risperidone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A diagnosis of dementia of the Alzheimer's type with or without a vascular component, a score of 2 or more on any item of the BEHAVE-AD psychosis subscale at screening, and a Mini-Mental State Examination (MMSE) score of 5 to 23
• Residents of nursing homes or long-term care facilities and deemed in need of treatment with an atypical antipsychotic medication.

Exclusion Criteria

• Disease that could significantly diminish cognitive function
• history of neuroleptic malignant syndrome
• hypersensitivity to risperidone.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

Mintzer J, Greenspan A, Caers I, Van Hove I, Kushner S, Weiner M, Gharabawi G, Schneider LS. Risperidone in the treatment of psychosis of Alzheimer disease: results from a prospective clinical trial. Am J Geriatr Psychiatry. 2006 Mar;14(3):280-91. doi: 10.1097/01.JGP.0000194643.63245.8c.

Reference Type: RESULT

PMID: 16505133 (View on PubMed)

Other Identifiers

CR002764

Identifier Type: -

Identifier Source: org_study_id