TerminatedPhase 3

A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimer's Disease

Double-blind, Placebo-controlled Clinical Trial of JK6476 (Risperidone) in Patients With Hallucinations and Delusions Associated With Alzheimer's Disease

Lead sponsor

Janssen Pharmaceutical K.K.

Asset

Risperidone

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic symptom

Identifiers

Registered as

Org study IDCR003172

NCT IDNCT00287742

Timeline

Milestones

Study start2002-03 (month precision)

Study completion2003-03actual (month precision)

Study first posted2006-02-07estimated

Last update posted2011-05-24estimated

Assets

Drug assets

Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Alzheimer's disease according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)

•Mini-Mental State Examination (MMSE) score of not greater than 23

•Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic score of >=2 for any item in the psychotic cluster

•occurrence of hallucination or delusion after onset of symptoms of dementia at least 28 days before screening

Exclusion criteria

•Patients with a disease that could significantly diminish cognitive function (e.g., Parkinsonism, Huntington's disease, Creutzfeldt-Jacob disease, dementia of Levy body type, vitamin B12 or folic acid deficiency)

•persistent dementia or amnestic disorders according to DSM-IV criteria

•occurrence of hallucination or delusion only while delirium is observed

•psychiatric symptoms induced by psychosis (e.g., schizophrenia, schizoaffective disorders, delusional disorders, depression or bipolar disorders)

•history of neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)

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

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Changes in BEHAVE-AD total, subscales and items scores, changes in CMAI aggressiveness and non-aggressiveness item scores and changes in CGI-C from baseline and intermediate visits to study end (Week 9) compared with placebo. Safety evaluations.

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Change in Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) psychotic symptom cluster score from baseline and intermediate visits to study end (Week 9) compared with placebo.

change from baseline, improvement

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.