Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

Not Applicable

Completed

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

• Registration Number: NCT01023867
• Lead Sponsor: Samsung Medical Center

Brief Summary

To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Detailed Description

The purposes of this study are:

1. to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia

2. to help to clinicians in choosing the best treatment for patients with mixed dementia

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. A diagnosis of probable AD and Mixed Dementia 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
Mixed Dementia group	donepezil	Patients with Mixed Dementia treated donepezil
Alzheimer's disease group	donepezil	Patients with Alzheimer's disease treated 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 City, Korea, Republic of