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

Not Applicable

Completed

• Conditions: Dementia; Alzheimer's Disease
• Interventions: Drug: donepezil

• Registration Number: NCT01023425
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
switching group	donepezil	switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
naive group	donepezil	naive patients with AD who initiated therapy with donepezil

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)	13 weeks, 26 weeks, 39 weeks, 52 weeks

Secondary Outcome Measures

Name	Time	Method
Seoul Activities of Daily Living (S-ADL)	13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)	13 weeks, 26 weeks, 39 weeks, 52 weeks
Korean Neuropsychiatric Inventory (K-NPI)	13 weeks, 26 weeks, 39 weeks, 52 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of