- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165724
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
December 10, 2021 updated by: Eisai Korea Inc.
Open study for efficacy and safety of donepezil treatment during 48 weeks
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bundang, Korea, Republic of
- Bobath Memorial Hospital
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Bundang, Korea, Republic of
- Bundang Seoul National University Hospital
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Changwon, Korea, Republic of
- Changwon Fatima Hospital
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Daegu, Korea, Republic of
- Yeungnam University Hospital
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Incheon, Korea, Republic of
- Inha University Hospital
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Seoul, Korea, Republic of
- Catholic University Hospital
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Seoul, Korea, Republic of
- Eulji University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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ADAS-cog
|
Secondary Outcome Measures
Outcome Measure |
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MMSE, CDR, GDS, NPI, ADL, SSDQ
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jiheed Mun, Eisai Korea Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2004
Primary Completion (Actual)
July 31, 2006
Study Completion (Actual)
December 31, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Actual)
December 30, 2021
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- EKI-1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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