Moderate to severe Alzheimers disease
Conditions
Interventions
investigational material(s)
Generic name etc : SUN Y7017
INN of investigational material : Memantine
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administr
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with dementia of Alzheimer's type on the DSM-IV-TR and probable Alzheimer' disease on NINCDS-ADRDA diagnostic criteria. 2.Patients diagnosed with Alzheimer's disease on CT or MRI intracerebral scans. 3.Patients with MMSE score between 1 and 14. 4. Patients receiving cholinesterase inhibitors continuously before the start of the screening period. Annotation; donepezil hydrochloride must be taken for at least 4 weeks before the start of the screening period.
Exclusion criteria
Exclusion criteria: 1.Patients with a coexisting dementia other than Alzheimer's disease. 2.Patients with serious neuropathy complications. 3.Patients with musculoskeletal diseases that will hamper conduct of tests and observations in the present study. 4.Others, patients deemed not suitable to take part in the present study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cognitive function Changes from baseline score (Week 24 - Week 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of behavioral and psychological symptoms of dementia, Evaluation by caregiver Changes from baseline score (Week 24- Week 0) | — |
Outcome results
None listed