severe Alzheimer'
Conditions
Interventions
donepezil hydrochloride 5mg/day and memantine hydrochloride 20mg/day
treatmet period: 52 weeks
donepezil hydrochloride 10mg/day
treatmet period: 52 weeks
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient diagnosed with dementia of the Alzheimerz's type based on the DSM-IV-TR and probable Alzheimer's disease on NINCDS-ADRDA 2.Patient diagnosed with Alzheimer's disease on MRI and SPECT intracerebral scans 3.Patient with severe Alzheimer's disease 4.Patient who has been treated with donepezil hydrochloride 5mg/day for at least 12 weeks before registration, and the patient who needs to change his/her treatment by the researcher's judgement 5.Patient's living environment allows for appropriate efficacy and safety evaluation in the present study 6.Patient who can visit the clinic with the information providers who can routinely observe his/her dementia symptoms, ADL and adverse events 7.Patient from whom consent has been appropriately obtained (informed consent should be obtained from the patient him/herself to the extent possible;consent must be obtained from patient's proxy consenter)
Exclusion criteria
Exclusion criteria: 1.Patient with dementia except for Alzheimer's disease 2.Patient with any of the following diseases or symtoms ? Severe impairment of heart, hepatic or renal ? Poorly controlled diabetes ? Serious neuropathy complications or musculoskeletal diseases ? Other poorly controlled diseases 3.Patient with a history of hyperesthesia to memantine hydrochloride 4.Patient with a history of the side effect at the dose escalation of cholinesterase inhibitor 5.Patient who have taken memantine hydrochloride within 24 weeks before registration 6.Other patients deemed not suitable to take part in the present study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? MMSE, NPI-D-J, CGI-C, FAST, J-ZBI_8 and QLDJ after 24 weeks ? Incidence of adverse events and adverse drug reactions until after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? MMSE, NPI-D-J, CGI-C, FAST, J-ZBI_8 and QLDJ after 52 weeks ? Incidence of adverse events and adverse drug reactions until after 52 weeks | — |
Countries
Japan
Outcome results
None listed