CompletedPhase 3

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

Efficacy And Safety Of A Flexible Dose Of Risperidone Versus Placebo In The Treatment Of Psychosis Of Alzheimer's Disease.

Lead sponsor

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

Asset

Risperidone

Listed sites

Recruiting sites

Enrollment

473

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 5-23

Primary endpoint

•Psychosis Cluster Score of Pathology from the Behavioral Pathology

Identifiers

Registered as

Org study IDCR002764

NCT IDNCT00034762

Timeline

Milestones

Study start2000-12 (month precision)

Study first posted2002-05-03estimated

Study completion2003-01actual (month precision)

Last update posted2011-02-01estimated

Assets

Drug assets

Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Change from baseline to end of treatment (Week 8) in Psychosis Cluster Score of Pathology from the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Rating Scale and Clinical Global Impression (CGI).

change from baseline, improvement

Secondary/protocol endpoint

Change in BEHAVE-AD total score and subscales (other than Psychosis Cluster subscale) from baseline; improvement in CGI scores during treatment; incidence of adverse events throughout study.

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID16505133via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.