Back to resultsCorrelation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DONEPEZIL HYDROCHLORIDE
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
- Cheonnam University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
MRI, ADAS-cog
Secondary Outcome Measures
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00165750
Brief Title
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Official Title
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients to enroll.
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.
4. Oversight
5. Study Description
Brief Summary
This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DONEPEZIL HYDROCHLORIDE
Other Intervention Name(s)
Aricept
Intervention Description
One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)
Primary Outcome Measure Information:
Title
MRI, ADAS-cog
Time Frame
0, 12, 24 weeks
Secondary Outcome Measure Information:
Title
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
Time Frame
0, 12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihee Mun
Organizational Affiliation
Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cheonnam University Hospital
City
Gwangju
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
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