Status:

COMPLETED

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

Lead Sponsor:

Eisai Korea Inc.

Conditions:

Alzheimer's Disease

Eligibility:

All Genders

40-90 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 30 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2006

    Estimated Enrollment :

    114 Patients enrolled

    Trial Details

    Trial ID

    NCT00165724

    Start Date

    June 30 2004

    End Date

    December 31 2006

    Last Update

    December 30 2021

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    Bobath Memorial Hospital

    Bundang, South Korea

    2

    Bundang Seoul National University Hospital

    Bundang, South Korea

    3

    Changwon Fatima Hospital

    Changwon, South Korea

    4

    Yeungnam University Hospital

    Daegu, South Korea