Alzheimer's Disease Long-term Follow-up Study (ALF Study)

• Sponsor: Eisai Korea Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00165724
• Collaborator: (none)
• Enrollment: 114
• Locations: 7
• Actual Duration (Months): 30
• Patients Per Site: 16.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Open study for efficacy and safety of donepezil treatment during 48 weeks

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Donepezil Hydrochloride	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Alzheimer's Disease Long-term Follow-up Study (ALF Study)
• Actual Study Start Date: Jun 30, 2004
• Actual Primary Completion Date: Jul 31, 2006
• Actual Study Completion Date: Dec 31, 2006

Outcome Measures

Primary Outcome Measures

1. ADAS-cog []

Secondary Outcome Measures

1. MMSE, CDR, GDS, NPI, ADL, SSDQ []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bobath Memorial Hospital	Bundang		Korea, Republic of
2	Bundang Seoul National University Hospital	Bundang		Korea, Republic of
3	Changwon Fatima Hospital	Changwon		Korea, Republic of
4	Yeungnam University Hospital	Daegu		Korea, Republic of
5	Inha University Hospital	Incheon		Korea, Republic of
6	Catholic University Hospital	Seoul		Korea, Republic of
7	Eulji University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Eisai Korea Inc.

Investigators

• Study Director: Jiheed Mun, Eisai Korea Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Korea Inc.
• ClinicalTrials.gov Identifier: NCT00165724
• Other Study ID Numbers: EKI-1002
• First Posted: Sep 14, 2005
• Last Update Posted: Dec 30, 2021
• Last Verified: Jun 1, 2010

• Additional relevant MeSH terms: Alzheimer Disease; Donepezil

Study Results

No Results Posted as of Dec 30, 2021