The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Jinan Mental Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Jinan Mental Hospital
ClinicalTrials.gov Identifier:
NCT00626613
First received: February 19, 2008
Last updated: February 29, 2008
Last verified: February 2008
  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)

Resource links provided by NLM:


Further study details as provided by Jinan Mental Hospital:

Primary Outcome Measures:
  • 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 ]

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
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626613

Locations
Taiwan
Department of Psychiatry Jinan Mental Hospital
Tainan, Taiwan, 717
Sponsors and Collaborators
Jinan Mental Hospital
Johnson & Johnson
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
  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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014