Back to resultsDonepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Primary Purpose
Dementia With Lewy Bodies (DLB)
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Donepezil
Donepezil
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia With Lewy Bodies (DLB) focused on measuring Dementia with Lewy bodies (DLB), FDG-PET
Eligibility 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
Sites / Locations
- Osaka University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
donepezil
Arm Description
Outcomes
Primary Outcome Measures
FDG-PET
Secondary Outcome Measures
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00776347
Brief Title
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Official Title
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies (DLB)
Keywords
Dementia with Lewy bodies (DLB), FDG-PET
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
donepezil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
Intervention Type
Drug
Intervention Name(s)
Donepezil
Primary Outcome Measure Information:
Title
FDG-PET
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Kazui, MD, PhD
Organizational Affiliation
Osaka University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka University Hospital
City
Suita,
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32346907
Citation
Kanemoto H, Kazui H, Adachi H, Yoshiyama K, Wada T, Nomura KT, Shimosegawa E, Ikeda M. Thalamic pulvinar metabolism, sleep disturbances, and hallucinations in dementia with Lewy bodies: Positron emission tomography and actigraphy study. Int J Geriatr Psychiatry. 2020 Aug;35(8):934-943. doi: 10.1002/gps.5315. Epub 2020 Jun 8.
Results Reference
derived
Links:
URL
http://www.med.osaka-u.ac.jp/index-e.html
Description
Related Info
Learn more about this trial
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
We'll reach out to this number within 24 hrs