The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
Recruitment status was Active, not recruiting
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Purpose
To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia Alzheimer's Disease |
Drug: Risperdal,reminyl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) |
| Official Title: | Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN) |
- 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 ]
-
Drug: Risperdal,reminyl
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Taiwan | |
| Department of Psychiatry Jinan Mental Hospital | |
| Tainan, Taiwan, 717 | |
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00626613 History of Changes |
| Other Study ID Numbers: | REM-TWN-MA5 |
| Study First Received: | February 19, 2008 |
| Last Updated: | February 29, 2008 |
| Health Authority: | Taiwan: Department of Health Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Galantamine Risperidone Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nootropic Agents Central Nervous System Agents Therapeutic Uses Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013