Status:
UNKNOWN
The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
Lead Sponsor:
Jinan Mental Hospital
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Dementia
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE4
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 BP...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00626613
Last Update
March 5 2008
Active Locations (1)
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1
Department of Psychiatry Jinan Mental Hospital
Tainan, Taiwan, 717