Official Title: “Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients”

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

Primary Measures

• MRI, ADAS-cog
  • Time Frame: 0, 12, 24 weeks
    Safety Issue?: Yes

Secondary Measures

• ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
  • Time Frame: 0, 12, 24 weeks
    Safety Issue?: No

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

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

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