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OpenTrials
Completed

NCT Number: NCT00165724

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

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

Completed

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bobath Memorial Hospital, Bundang, South Korea

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil Hydrochloride

Drug

Primary outcomes

  1. ADAS-cog

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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