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

This study has been completed.
Sponsor:
Collaborator:
Eisai Korea Inc.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01023867
First received: November 30, 2009
Last updated: January 4, 2016
Last verified: January 2016
History of Changes
  Purpose
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Condition Intervention
Alzheimer's Disease
Dementia
 Drug: donepezil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Seoul Activities of Daily Living (S-ADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Seoul-Instrumental Activities of Daily Living (S-IADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Korean Neuropsychiatric Inventory (K-NPI) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
Enrollment: 88
Study Start Date: March 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 30, 2009
Last Updated: January 4, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016