Trial record 10 of 33 for:
"Dementia With Lewy Bodies"
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:
|
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 May 19, 2013