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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. 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
Johnson & Johnson
Information provided by:
Jinan Mental Hospital

Brief Summary:
To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Drug: Risperdal,reminyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Official Title: Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN)

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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.
  2. Subjects and subjects' relatives or legal representatives have signed the informed consent form, in accordance with the regulations of the local ethical committee.
  3. Subjects must remain in good health, as determined by medical history, complete physical examinations, laboratory tests and ECG.

Exclusion Criteria:

  1. Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease.
  2. 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

  3. Multi-infarct dementia or clinically active cerebrovascular disease
  4. Subjects with the severe co-existing medical conditions.
  5. Current clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 3-month trial.
  6. History of drug or alcohol abuse within the last year.
  7. Female subjects of childbearing potential without adequate contraception.
  8. History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to Risperidone.
  9. Participation in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626613

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Department of Psychiatry Jinan Mental Hospital
Tainan, Taiwan, 717
Sponsors and Collaborators
Jinan Mental Hospital
Johnson & Johnson
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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

Layout table for additonal information Identifier: NCT00626613     History of Changes
Other Study ID Numbers: REM-TWN-MA5
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents