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

NCT ID: NCT00165724

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Donepezil Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiheed Mun

Role: STUDY_DIRECTOR

Eisai Korea Inc.

Locations

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Bobath Memorial Hospital

Bundang, , South Korea

Site Status

Bundang Seoul National University Hospital

Bundang, , South Korea

Site Status

Changwon Fatima Hospital

Changwon, , South Korea

Site Status

Yeungnam University Hospital

Daegu, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Catholic University Hospital

Seoul, , South Korea

Site Status

Eulji University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EKI-1002

Identifier Type: -

Identifier Source: org_study_id