Back to resultsAlzheimer's Disease Long-term Follow-up Study (ALF Study)
Primary Purpose
Alzheimer's Disease
Status
Completed
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 Men or women aged 40 to 90 Diagnosis of dementia according to DSM-IV Diagnosis of probable AD as defined by NINCDS-ADRDA criteria Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26 Patients were generally healthy and ambulatory or ambulatory aided Patients did not take acetylcholinesterase inhibitor 4 weeks before screening Patients have useful MRI results 3 months before screening Exclusion If they have evidence of TIA or major infarction Epilepsy patients If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse If they sensitive to acetylcholinesterase If they taken concomitant medication which were not allowed
Sites / Locations
- Bobath Memorial Hospital
- Bundang Seoul National University Hospital
- Changwon Fatima Hospital
- Yeungnam University Hospital
- Inha University Hospital
- Catholic University Hospital
- Eulji University Hospital
Outcomes
Primary Outcome Measures
ADAS-cog
Secondary Outcome Measures
MMSE, CDR, GDS, NPI, ADL, SSDQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00165724
Brief Title
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Official Title
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 30, 2004 (Actual)
Primary Completion Date
July 31, 2006 (Actual)
Study Completion Date
December 31, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.
4. Oversight
5. Study Description
Brief Summary
Open study for efficacy and safety of donepezil treatment during 48 weeks
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
114 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Donepezil Hydrochloride
Primary Outcome Measure Information:
Title
ADAS-cog
Secondary Outcome Measure Information:
Title
MMSE, CDR, GDS, NPI, ADL, SSDQ
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Eligibility Criteria
Inclusion criteria
Men or women aged 40 to 90
Diagnosis of dementia according to DSM-IV
Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
Patients were generally healthy and ambulatory or ambulatory aided
Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
Patients have useful MRI results 3 months before screening
Exclusion
If they have evidence of TIA or major infarction
Epilepsy patients
If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
If they sensitive to acetylcholinesterase
If they taken concomitant medication which were not allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiheed Mun
Organizational Affiliation
Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bobath Memorial Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Bundang Seoul National University Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Changwon Fatima Hospital
City
Changwon
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Catholic University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
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