DLB
Conditions
Interventions
Medication of Donepezil (3-10mg per day) for 12 weeks.
Sponsors
Promedico Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)met criteria of probable DLB in CDLB 3rd 2)gave informed consent 3)60 years old or more of age 4)outpatients or home visited patients 5)have carer spend time with 72 hours or more every week 6)not dozed Donepezil within 12 weeks before informed consent
Exclusion criteria
Exclusion criteria: 1)dozed antidementia drugs except Donepezil within 12 weeks before informed consent 2)bed ridden 3)with severe impairment of visual acuity, auditory sensor and/or communication 4)with neurological degenerative disease except for DLBV criteria, schizophrenia, bipolar disorder and major depression 5)with delirium due to abuse of alcohol, drugs, metabolic toxicity and inflammation 6)inadequate decided by principal investigator 7)with hypersensitivity to components of Donepezil or piperidine derivative 8)dozed investigational drug within 12 weeks before informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes on SDI-DLB 4, and 12 weeks after starting medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in scales of MMSE, EQ-5D and PSMS at 12 weeks after starting medication. | — |
Countries
Japan
Contacts
Public ContactAsako Yasuda
Promedico Co., Ltd. Projects Promotion Department
Outcome results
None listed