None listed
Conditions
Interventions
None listed
Sponsors
Lundbeck Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has signed on the informed consent form (ICF) by their own or through a legal representative. 2) The patient has a diagnosis of moderate to severe AD based on ICD-10 criteria and meet the following baseline cut-off scores for the Mini Mental State Examination, Clinical Dementia Rating, Global Deterioration Scale, respectively: 5 = Mini Mental State Examination = 20 Clinical Dementia Rating 2-3 or Global Deterioration Scale 4-7 3) The patient is treated with Ebixa tablets 10mg or 20mg (memantine hydrochloride) for AD (as monotherapy or combination therapy) in compliance with the local SmPC. 4) The patient is aged = 50 years at baseline
Exclusion criteria
Exclusion criteria: 1) Patients who meet any contraindications listed in the product labeling for Ebixa® (refer to the prescribing information): - Known hypersensitivity to any component of the study drug - Severe hepatic impairment - Severe renal impairment (creatinine clearance < 5 mL/min) 2) Patients who have participated in another clinical trial involving dementia treatments within the past 3 months 3) Patients who have received any Alzheimer’s disease treatment containing memantine hydrochloride within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDR(Clinical Dementia Rating) | — |
Secondary
| Measure | Time frame |
|---|---|
| Administration status of the study drug;Administration status of concomitant medications (antipsychotics, antidepressants, sedatives/hypnotics, anticonvulsants, anxiolytics);NPI (Neuropsychiatric Inventory);MMSE (Mini Mental State Examination);ZBI (Zarit Burden Interview);Rate of Adverse Events and Serious Adverse Events (%) | — |
Countries
Korea, Republic of
Contacts
Public ContactKee Hyung Park
Gachon University Gil Medical Center
Outcome results
None listed