Clinical Trial of Donepezil Between the Naive Group and the Switching Group

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

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

Brief Summary

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To compare the clinical efficacy of donepezil between the naive group and the switching group.

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Detailed Description

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The purposes of this study are:

1. to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
2. to help to clinicians in choosing the best treatment

Conditions

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Alzheimer's Disease Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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switching group

switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately

Group Type EXPERIMENTAL

donepezil

Intervention Type DRUG

from 5mg to 10mg, once a day, 12 months

naive group

naive patients with AD who initiated therapy with donepezil

Group Type EXPERIMENTAL

donepezil

Intervention Type DRUG

from 5mg to 10mg, once a day, 12 months

Interventions

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donepezil

from 5mg to 10mg, once a day, 12 months

Intervention Type DRUG

Other Intervention Names

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donepezil-aricept

Eligibility Criteria

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Inclusion Criteria

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.

Eligible Sex

ALL

Accepts Healthy Volunteers

No