The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)

Tracking Information
First Submitted Date ICMJE	February 19, 2008
First Posted Date ICMJE	February 29, 2008
Last Update Posted Date	March 5, 2008
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: February 28, 2008)	Neoropsychiatric Inventory (NPI)Cognitive Abilities Screening Instrument (CASI) SF-36abnormal involuntary movement scale (AIMS), Barnes akathisia rating scale (BARS), and Simpson angus scale (SAS) [ Time Frame: one year ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00626613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
Official Title ICMJE	Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN)
Brief Summary	To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.
Detailed Description	This is an interventional, placebo-controlled, double blind, prospective study. The total duration of this study will be 12 weeks. (1). Baseline Phase: Subjects diagnosed as Alzheimer's Disease and BPSD will be evaluated for entry to the trial. Subjects must meet the inclusion/exclusion criteria before entering the treatment phase. After obtaining informed consent, a physical examination, brief neurologic examination, and clinical laboratory tests appropriate are recommended. (2). Treatment Phase: All patients enrolled will be randomized to treatment with Risperdal Oral Solution or Placebo. The dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg) (as the local product information leaflet). Investigators can titrate dosage according to patients' clinical situation. The maximum dose will be 2ml/ per day. The standardized assessments include NPI, which covers 12 domains of behavioral and neuro-vegetative symptoms, CASI for cognitive function test, and SF-36 for Quality of Life. Adverse events will be recorded.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: Double (Participant, Care Provider)
Condition ICMJE	Dementia; Alzheimer's Disease
Intervention ICMJE	Drug: Risperdal,reminyl; Risperdal:The dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg), The maximum dose will be 2ml/ per day reminyl:8 mg/ per day
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Male or female patients whose age 60 years or older diagnosed with Alzheimer's disease and BPSD without exposure to any antipsychotics within 1 month prior to study start.; Subjects and subjects' relatives or legal representatives have signed the informed consent form, in accordance with the regulations of the local ethical committee.; Subjects must remain in good health, as determined by medical history, complete physical examinations, laboratory tests and ECG. Exclusion Criteria: Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease.; One of the following conditions possibly resulting in cognitive impairment: Acute cerebral trauma caused by post traumatic brain injury, subdural hematoma and injuries secondary to chronic trauma; hypoxic cerebral damage;; cerebral neoplasia;; mental retardation or oligophrenia; Multi-infarct dementia or clinically active cerebrovascular disease; Subjects with the severe co-existing medical conditions.; Current clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 3-month trial.; History of drug or alcohol abuse within the last year.; Female subjects of childbearing potential without adequate contraception.; History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to Risperidone.; Participation in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry.
Sex/Gender	Sexes Eligible for Study: All
Ages	60 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Taiwan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00626613
Other Study ID Numbers ICMJE	REM-TWN-MA5
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Jinan Mental Hospital
Collaborators ICMJE	Johnson & Johnson
Investigators ICMJE	Principal Investigator: Ouyang Wen-Chen, Doctor of Public Health Taiwanese Society of Psychiatry,Boarding member;Zeelandia Dementia Boarding member;Boarding member, Taiwanese Association of Geriatric Psychiatry ;Taiwan Dementia Society Boarding member
PRS Account	Jinan Mental Hospital
Verification Date	February 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP