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CompletedPhase 3

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

A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone for Treatment of Behavioral Disturbances in Subjects With Dementia

Lead sponsor

Janssen, LP

Asset

Risperidone

Listed sites

0

Recruiting sites

-

Enrollment

626

actual

Study population

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

Key I/E criteria

•Multiple dementia etiologies•MMSE 23

Primary endpoint

•>= 30% from baseline to the end of double-blind treatment on the total

Identifiers

Registered as

Org study IDCR006022
NCT IDNCT00253123

Timeline

Milestones

Study completion1997-03actual (month precision)
Study first posted2005-11-15estimated
Last update posted2010-12-03estimated

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 a diagnosis of 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)
•a score of 4 or more on the Functional Assessment Staging (FAST), a diagnostic tool for determining the stage of dementia
•a score of 23 or lower on the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition
•a BEHAVE-AD total score of at least 8, and a BEHAVE-AD global rating of at least 1
•residence in a psychiatric hospital, nursing home, or other long-term care facility for at least 1 month

Exclusion criteria

•Patients with untreated, reversible causes of dementia
•with general medical or neurological conditions in which cognition is diminished (for example, untreated vitamin deficiency, severe liver or kidney malfunctions, brain tumor, etc.)
•with dementia related to HIV infection (human immunodeficiency virus)
•with a substance-induced persisting dementia
•with psychiatric disorders that could account for the behavior disturbances, such as schizophrenia.

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

Behavior / neuropsychiatric
1
Other (unclassified)
1

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from baseline to the end of double-blind treatment in BEHAVE-AD global rating and total score; total CMAI score; CGI and CGI change from baseline; PSMS; safety evaluations conducted throughout the study.

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.

descriptive

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

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.