NCT Number: NCT00165724
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Open study for efficacy and safety of donepezil treatment during 48 weeks
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Notify MeKey information
Conditions
Age range
40 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Bobath Memorial Hospital, Bundang, South Korea
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
ADAS-cog
Secondary outcomes
-
MMSE, CDR, GDS, NPI, ADL, SSDQ
Sponsors and collaborators
Lead sponsor
Eisai Korea Inc.
Industry
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Sep 14, 2005
- Registry last updated
- Dec 30, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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