The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
This trial is active, not recruiting.
|Conditions||dementia, alzheimer's disease|
|Sponsor||Jinan Mental Hospital|
|Collaborator||Johnson & Johnson|
|Trial identifier||NCT00626613, REM-TWN-MA5|
To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver)|
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
Male or female participants at least 60 years old.
- 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.
- 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.
|Official title||Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN)|
|Principal investigator||Ouyang Wen-Chen, Doctor of Public Health|
|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.|
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