Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
This study is currently recruiting participants.
Verified December 2012 by Osaka University
Sponsor:
Osaka University
Information provided by (Responsible Party):
Hiroaki Kazui, Osaka University
ClinicalTrials.gov Identifier:
NCT00776347
First received: October 20, 2008
Last updated: December 9, 2012
Last verified: December 2012
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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 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Donepezil
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
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
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: | December 9, 2012 |
| 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:
|
Dementia Lewy Body Disease 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 May 16, 2013