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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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:
- 1. Over 60 years old.
- 2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
- 3. MMSE score of 10~24, CDR of 1~2.
- 4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
- 5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.
Exclusion criteria:
- 1. Uncontrolled by donepezil because of adverse events.
- 2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
- 3. If they have 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 Investigator Information
Lead Investigator: Eisai Korea Inc. Industry
Overall Clinical Trial Officials and Contacts
Jihee Mun Study Director Eisai Korea Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00165750
