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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 Behavioural and Psychological Signs and Symptoms in Dementia (BPSSD): a Multicentre, Double-blind, Placebo-controlled Parallel-group Trial

Asset

Risperidone

Listed sites

0

Recruiting sites

-

Enrollment

344

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE ≤23

Primary endpoint

•Total aggression score of the CMAI

Identifiers

Registered as

Org study IDCR006010
NCT IDNCT00249158

Timeline

Milestones

Study start1998-03 (month precision)
Study completion2001-02actual (month precision)
Study first posted2005-11-07estimated
Last update posted2010-11-19estimated

Assets

Drug assets

Risperidone

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Dementia of the Alzheimer's type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition)
•a score >=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score <=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition)
•a BEHAVE-AD (Behavior Pathology in Alzheimer's Disease Rating Scale) total score >=8, and a BEHAVE-AD global rating >=1
•patient must be living in an nursing home for >=1 month

Exclusion criteria

•Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
•diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder
•history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs)
•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
1
Behavior / neuropsychiatric
1

Global cognition

1 endpoint
Secondary/protocol endpoint

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

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).

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

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.