- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626613
The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)
February 29, 2008 updated by: Jinan Mental Hospital
Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN)
To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan, 717
- Department of Psychiatry Jinan Mental Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (ESTIMATE)
February 29, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
March 5, 2008
Last Update Submitted That Met QC Criteria
February 29, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Nootropic Agents
- Cholinesterase Inhibitors
- Parasympathomimetics
- Risperidone
- Galantamine
Other Study ID Numbers
- REM-TWN-MA5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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