Status:
COMPLETED
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
Open study for efficacy and safety of donepezil treatment during 48 weeks
Eligibility Criteria
Inclusion
- Inclusion criteria
- Men or women aged 40 to 90
- Diagnosis of dementia according to DSM-IV
- Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
- Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
- Patients were generally healthy and ambulatory or ambulatory aided
- Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
- Patients have useful MRI results 3 months before screening
- Exclusion
- If they have evidence of TIA or major infarction
- Epilepsy patients
- If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
- If they sensitive to acetylcholinesterase
- If they taken concomitant medication which were not allowed
Exclusion
Key Trial Info
Start Date :
June 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2006
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00165724
Start Date
June 30 2004
End Date
December 31 2006
Last Update
December 30 2021
Active Locations (7)
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1
Bobath Memorial Hospital
Bundang, South Korea
2
Bundang Seoul National University Hospital
Bundang, South Korea
3
Changwon Fatima Hospital
Changwon, South Korea
4
Yeungnam University Hospital
Daegu, South Korea