Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedOctober 15, 2015
October 1, 2015
6.3 years
October 20, 2008
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FDG-PET
14 weeks
Secondary Outcomes (1)
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
14 weeks
Study Arms (1)
donepezil
EXPERIMENTALInterventions
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
Eligibility Criteria
You may qualify if:
- DLB patients:
- who fulfill the diagnostic criteria of DLB
- 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
- to 85 years old
- right-handed
- MMSE score over 24
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
Study Sites (1)
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Related Publications (1)
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.
PMID: 32346907DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroaki Kazui, MD, PhD
Osaka University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D,Ph.D
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 21, 2008
Study Start
October 1, 2008
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 15, 2015
Record last verified: 2015-10