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UnknownPhase 4

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)

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

NCT IDNCT00626613
Org study IDREM-TWN-MA5

Timeline

Milestones

Study first posted2008-02-29estimated
Last update posted2008-03-05estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersAccepted

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 endpoint
Primary/protocol endpoint

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

Neuropsychiatric Inventory (NPI)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.