Clinical Trials List
2007-11-01 - 2009-12-31
Phase III
Terminated4
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release to 10 mg Donepezil Immediate Release in Patients with Moderate to Severe Alzheimer’s Disease
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Sponsor
Eisai Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳韋達 Division of Neurology
- Shuu-Jiun Wang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chiou-Lian Lai Division of Neurology
- MEI-CHUAN CHOU Division of Neurology
- Chien-Hsun Li Division of Neurology
- Yuan-Han Yang Division of Neurology
The Actual Total Number of Participants Enrolled
10 Terminated
Audit
CRO
Co-Principal Investigator
- 林書漢 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
1) The consent form of the subject will be signed by the patient (if possible) or the legal guardian or other legal representative of the patient before the screening visit. Even if the signed subject consent form cannot be obtained, the patient must verbally agree to participate in this clinical trial, and this consent process should be added to the medical record. The caregivers themselves must separately sign the consent form of the subjects participating in this clinical trial.
2) Age range: 45 to 90-year-old adults.
3) Gender distribution: male and female. Women must have no possibility of conception (menopause for more than 1 year or inability to have children after surgery)
Exclusion Criteria
1) The patient a. did not take drugs to treat Alzheimer's disease; b. took Aricept® or donepezil before the screening visit, the daily dose of the bio-equivalent generic drug is not 10mg, or 10mg <3 months; c. Other medications for Alzheimer's disease, except for the following:
a. Take memantine 20 mg daily for at least 3 months before the screening visit.
b. A stable dose of vitamin E and/or fish oil has been taken for at least 3 months before the screening visit, and the dose remained the same during the trial period.
The Estimated Number of Participants
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Taiwan
80 participants
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Global
1600 participants
