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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)
Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN)
Lead sponsor
Asset
Risperidone / Galantamine
Listed sites
1
Recruiting sites
-
Enrollment
-
Study population
Alzheimer’s disease
Key I/E criterion
•Alzheimer's disease
Primary endpoint
•Neuropsychiatric Inventory (NPI)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Behavior / neuropsychiatric
1 endpointNeoropsychiatric 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
Neuropsychiatric Inventory (NPI)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.