Dementia With Lewy Bodies (DLB)
Conditions
Keywords
Dementia with Lewy bodies (DLB), FDG-PET
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.
Interventions
DRUGDonepezil
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
Sponsors
Osaka University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FDG-PET | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver | 14 weeks |
Countries
Japan
Outcome results
None listed