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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00165724
Enrollment
114
Registered
2005-09-14
Start date
2004-06-30
Completion date
2006-12-31
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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

Interventions

DRUGDonepezil Hydrochloride

Sponsors

Eisai Korea Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frame
ADAS-cog

Secondary

MeasureTime frame
MMSE, CDR, GDS, NPI, ADL, SSDQ

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026