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Trial record 61 of 332 for:    DONEPEZIL

Clinical Trial of Donepezil Between the Naive Group and the Switching Group

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ClinicalTrials.gov Identifier: NCT01023425
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

Brief Summary:
To compare the clinical efficacy of donepezil between the naive group and the switching group.

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 efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
  2. to help to clinicians in choosing the best treatment

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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 Naive Group and the Switching Group
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009


Arm Intervention/treatment
Experimental: switching group
switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
Drug: donepezil
from 5mg to 10mg, once a day, 12 months
Other Name: donepezil-aricept

Experimental: naive group
naive patients with AD who initiated therapy with donepezil
Drug: donepezil
from 5mg to 10mg, once a day, 12 months
Other Name: donepezil-aricept




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 ]


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

Inclusion Criteria:

  1. A diagnosis of probable AD 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.

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): NCT01023425


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Eisai Korea Inc.
Investigators
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Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center

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Responsible Party: Doh Kwan Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01023425     History of Changes
Other Study ID Numbers: 2008-02-072
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:
naive group
switching group
treatment response
Efficacy
Adverse event
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents