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

December 10, 2021 updated by: Eisai Korea Inc.
Open study for efficacy and safety of donepezil treatment during 48 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bundang, Korea, Republic of
        • Bobath Memorial Hospital
      • Bundang, Korea, Republic of
        • Bundang Seoul National University Hospital
      • Changwon, Korea, Republic of
        • Changwon Fatima Hospital
      • Daegu, Korea, Republic of
        • Yeungnam University Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Seoul, Korea, Republic of
        • Catholic University Hospital
      • Seoul, Korea, Republic of
        • Eulji University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ADAS-cog

Secondary Outcome Measures

Outcome Measure
MMSE, CDR, GDS, NPI, ADL, SSDQ

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jiheed Mun, Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2004

Primary Completion (Actual)

July 31, 2006

Study Completion (Actual)

December 31, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Actual)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

June 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Donepezil Hydrochloride

3
Subscribe