This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease...
Date First Received: September 12, 2005
Last Updated: March 21, 2008
Verified by: Eisai Medical Research Inc., March 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2005
Overall Status: Recruiting
Estimated Enrollment: 80
Brief Summary
Official Title: “Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients”
Condition Keyword(s):
Intervention(s):
This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Study Primary Completion Date: August 2008
Intervention(s) in this Clinical Trial
- Drug: DONEPEZIL HYDROCHLORIDE
- One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- MRI, ADAS-cog
- Time Frame: 0, 12, 24 weeks
Safety Issue?: Yes
- Time Frame: 0, 12, 24 weeks
Secondary Measures
- ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
- Time Frame: 0, 12, 24 weeks
Safety Issue?: No
- Time Frame: 0, 12, 24 weeks
Criteria for Participation in this Clinical Trial
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 drug: antipsychotic drug for BPSD, antidepressant drug, tranquilizer, treatment drug for physical disease for example hypertension.
Exclusion criteria:
- uncontrolled by donepezil because of adverse events
- No longer continuancely treatment of donepezil for refuse, drug-drug interaction etc.
- If they taken concomitant medication which were not allowed
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Eisai Korea Inc.
Overall Clinical Trial Officials and Contacts
Jihee Mun Study Director Eisai Korea Inc.
Overall Contact: Yukihiko Yokobatake y-yokobatake@hhc.eisai.co.jp
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00165750
Study ID Number: AS-019 (EKI-5-003)
ClinicalTrials.gov Identifier: NCT00165750
Health Authority: Korea: Food and Drug Administration
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