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

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ClinicalTrials.gov Identifier: NCT01023867
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Condition or disease Intervention/treatment
Alzheimer's Disease Dementia Drug: donepezil

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

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
Primary Completion Date : June 2010
Study Completion Date : June 2010


Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023867


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

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