CompletedPhase 3

A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia

Risperidone in the Treatment of Behavioral Disturbances in Demented Patients: an International, Multicenter, Placebo-controlled, Double-blind, Parallel-group Trial Using Haloperidol as Internal Reference

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Asset

Risperidone

Listed sites

Recruiting sites

Enrollment

349

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE ≤23

Primary endpoint

•Change

Identifiers

Registered as

Org study IDCR006046

NCT IDNCT00249145

Timeline

Milestones

Study start1995-04 (month precision)

Study completion1996-12actual (month precision)

Study first posted2005-11-07estimated

Last update posted2011-01-14estimated

Assets

Drug assets

Risperidone

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with 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]) and have behavioral disturbances

•a score >=4 on the FAST

•a score <=23 on the MMSE

•a BEHAVE-AD total score >=8, and a BEHAVE-AD global rating >=1

•must be institutionalized

Exclusion criteria

•Patients with other medical or neurological conditions in which cognition (thinking, perception, learning, verbal communication, memory, judgment) is diminished (for example, drug overdosage, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)

•other psychiatric disorders, including major depression, schizophrenia, substance abuse or dependence

•abnormal electrocardiogram (ECG) findings

•abnormal clinical laboratory test findings.

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.

Coverage by outcome category

Global cognition

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

Change from baseline to end of double-blind treatment in global rating, total BEHAVE-AD score, total CMAI score, CGI severity, FAST, and MMSE; safety evaluations conducted throughout the study

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.

change from baseline, improvement

Publications (2)

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

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.