The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00626613 |
Recruitment Status
: Unknown
Verified February 2008 by Jinan Mental Hospital.
Recruitment status was: Active, not recruiting
First Posted
: February 29, 2008
Last Update Posted
: March 5, 2008
|
Sponsor:
Jinan Mental Hospital
Collaborator:
Johnson & Johnson
Information provided by:
Jinan Mental Hospital
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 |
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 |
|
|||
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
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 |