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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Osaka University
Sponsor:
Information provided by (Responsible Party):
Hiroaki Kazui, Osaka University
ClinicalTrials.gov Identifier:
NCT00776347
First received: October 20, 2008
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention
Dementia With Lewy Bodies (DLB)
Drug: Donepezil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Osaka University:

Primary Outcome Measures:
  • FDG-PET [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT00776347

Contacts
Contact: Hiroaki Kazui, MD, PhD +81-6-6879-3051 ext 3058 kazui@psy.med.osaka-u.ac.jp

Locations
Japan
Osaka University Hospital Recruiting
Suita,, Osaka, Japan, 565-0871
Contact: Hiroaki Kazui, MD, PhD    +81-6-6879-3051 ext 3058    kazui@psy.med.osaka-u.ac.jp   
Principal Investigator: Hiroaki Kazui, MD PhD         
Sponsors and Collaborators
Osaka University
Investigators
Principal Investigator: Hiroaki Kazui, MD, PhD Osaka University
  More Information

Additional Information:
No publications provided

Responsible Party: Hiroaki Kazui, M.D,Ph.D, Osaka University
ClinicalTrials.gov Identifier: NCT00776347     History of Changes
Other Study ID Numbers: OSK-08096
Study First Received: October 20, 2008
Last Updated: November 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:
Dementia with Lewy bodies (DLB)
FDG-PET

Additional relevant MeSH terms:
Lewy Body Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014