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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165724
• Other study ID #: EKI-1002
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2004
• Est. completion date: December 31, 2006

Study information

• Verified date: June 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 31, 2006
• Est. primary completion date: July 31, 2006
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil Hydrochloride

Locations

Country	Name	City	State
Korea, Republic of	Bobath Memorial Hospital	Bundang
Korea, Republic of	Bundang Seoul National University Hospital	Bundang
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Catholic University Hospital	Seoul
Korea, Republic of	Eulji University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-cog
Secondary	MMSE, CDR, GDS, NPI, ADL, SSDQ