NCT00249158

Brief Summary

The purpose of the study is to compare the effectiveness of an oral formulation of risperidone (an antipsychotic medication) to that of placebo for treating behavioral and psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and hallucinations, in patients with dementia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 1998

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

First QC Date

November 4, 2005

Last Update Submit

November 18, 2010

Conditions

DementiaAlzheimer DiseaseVascular Dementia

Keywords

DementiaAlzheimer's Diseasevascular dementiamixed dementiarisperidonenursing home

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

RisperidoneDRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Brodaty H, Ames D, Snowdon J, Woodward M, Kirwan J, Clarnette R, Lee E, Lyons B, Grossman F. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry. 2003 Feb;64(2):134-43. doi: 10.4088/jcp.v64n0205.

    PMID: 12633121RESULT

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDementia, VascularMixed Dementias

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen-Cilag Pty Ltd Clinical Trial

    Janssen-Cilag Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

March 1, 1998

Study Completion

February 1, 2001

Last Updated

November 19, 2010

Record last verified: 2010-11