Status:
TERMINATED
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Over 60 years old.
- Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
- MMSE score of 10\~24, CDR of 1\~2.
- Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
- Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.
- Exclusion criteria:
- Uncontrolled by donepezil because of adverse events.
- No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
- If they have taken concomitant medication which were not allowed.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00165750
Start Date
March 1 2005
End Date
November 1 2008
Last Update
November 20 2013
Active Locations (1)
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1
Cheonnam University Hospital
Gwangju, Gwangju, South Korea