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

NCT00626613 | Unknown Phase 4

• 1 other identifier: REM-TWN-MA5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dementia; Alzheimer's Disease

Outcome Measures

Primary Outcomes (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)

  one year

Interventions

Risperdal,reminyl DRUG

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan Mental Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Department of Psychiatry Jinan Mental Hospital

Tainan, 717, Taiwan

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Risperidone; Galantamine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amaryllidaceae Alkaloids; Alkaloids; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 29, 2008
• Last Updated: March 5, 2008

Record last verified: 2008-02

Locations

TW (1)