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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease; Dementia	Drug: donepezil	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	88 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Study Start Date :	March 2007
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Alzheimer's disease group; Patients with Alzheimer's disease treated donepezil	Drug: donepezil; from 5mg to 10mg, once a day, 12 months; Other Name: donepezil-aricept
Experimental: Mixed Dementia group; Patients with Mixed Dementia treated donepezil	Drug: donepezil; from 5mg to 10mg, once a day, 12 months; Other Name: donepezil-aricept

Outcome Measures

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Primary Outcome Measures :

1. Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]

Secondary Outcome Measures :

1. Seoul Activities of Daily Living (S-ADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
2. Seoul-Instrumental Activities of Daily Living (S-IADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
3. Korean Neuropsychiatric Inventory (K-NPI) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Samsung Medical Center
Seoul City, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Eisai Korea Inc.

Investigators

Principal Investigator:	Doh Kwan Kim, PhD, M.D.	Samsung Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Doh Kwan Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01023867 History of Changes
Other Study ID Numbers:	2007-03-039
First Posted:	December 2, 2009
Last Update Posted:	January 6, 2016
Last Verified:	January 2016

Keywords provided by Doh Kwan Kim, Samsung Medical Center:

Alzheimer's disease; Mixed Dementia; Donepezil; Efficacy; Adverse Event

Additional relevant MeSH terms:

Alzheimer Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dementia; Tauopathies	Donepezil; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Nootropic Agents