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Trial record 51 of 332 for:    DONEPEZIL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01023867
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
Eisai Korea Inc.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01023867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • Seoul Activities of Daily Living (S-ADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
  • Seoul-Instrumental Activities of Daily Living (S-IADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
  • Korean Neuropsychiatric Inventory (K-NPI) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Official Title  ICMJE Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Dementia
Intervention  ICMJE Drug: donepezil
from 5mg to 10mg, once a day, 12 months
Other Name: donepezil-aricept
Study Arms  ICMJE
  • Experimental: Alzheimer's disease group
    Patients with Alzheimer's disease treated donepezil
    Intervention: Drug: donepezil
  • Experimental: Mixed Dementia group
    Patients with Mixed Dementia treated donepezil
    Intervention: Drug: donepezil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
88
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
100
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01023867
Other Study ID Numbers  ICMJE 2007-03-039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Doh Kwan Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Eisai Korea Inc.
Investigators  ICMJE
Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP