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Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

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: NCT00776347
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Hiroaki Kazui, Osaka University

Study Description
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Brief Summary:
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies (DLB) Drug: Donepezil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Study Start Date : October 2008
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: donepezil Drug: Donepezil
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks

Drug: Donepezil


Outcome Measures
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Primary Outcome Measures :
  1. FDG-PET [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver [ Time Frame: 14 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

DLB patients:

  • who fulfill the diagnostic criteria of DLB
  • 60 to 85 years old
  • right-handed
  • Clinical Dementia Rating (CDR) ≧ 0.5
  • Mini Mental State Examination (MMSE) score from 10 to 26

Normal Controls:

  • who are independent
  • who have no subjective or objective cognitive impairment
  • 60 to 85 years old
  • right-handed
  • MMSE score over 24

Exclusion Criteria:

DLB patients:

  • who have diabetes mellitus
  • who have pathological change on MRI other than brain atrophy
  • who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
  • who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
  • who have severe digestive ulcus
  • who have severe bronchitic asthma or obstructive lung disease
  • who have no caregiver who knows patient's condition well

Normal Controls:

  • who have diabetes mellitus
  • who have taken donepezil before
  • who have abnormal findings on MRI
  • who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function
Contacts and Locations
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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): NCT00776347


Locations
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Japan
Osaka University Hospital
Suita,, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Investigators
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Principal Investigator: Hiroaki Kazui, MD, PhD Osaka University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hiroaki Kazui, M.D,Ph.D, Osaka University
ClinicalTrials.gov Identifier: NCT00776347    
Other Study ID Numbers: OSK-08096
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015
Keywords provided by Hiroaki Kazui, Osaka University:
Dementia with Lewy bodies (DLB)
FDG-PET
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
 Movement Disorders
Synucleinopathies
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents