Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)

Inclusion criteria

• ≥55 and ≤85 years of age
• Patient who was diagnosed mild to moderate Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) or National Institute on Aging-Alzheimer's Association(NIAAA)
• Korean Mini-Mental State Examination(K-MMSE) score 15 to 26
• Patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1)
• Clinical Dementia Rating(CDR) score 0.5 to 2.0 at screening (visit 1)
• Written informed consent voluntarily
• Patient who has a relative/caregiver who support the information of patient's status
• Patient who are deemed adequate to participate in the clinical trial by the investigator
• Infertility or patients and his/her spouse consent with contraception during the study period

Exclusion criteria

• A diagnosis of vascular dementia or dementia by other cause according to the criteria of the NINCDS-ADRDA
• Structural brain abnormality or impairment
• Schizophrenia, depressive disorder and bipolar disorder
• Any neurological disease except Alzheimer' disease (ex. Parkinson's disease, Huntington's disease, brain tumor, normal-pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, epilepsy, delusion and head injury required hospitalization)
• History of any cancer within previous 5 years
• History of stroke within previous 2 years
• Heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year
• Uncontrollable diabetes
• Uncontrollable hypertension
• Abnormal liver or kidney function
• Patient with significant clinical meaning to affect cognitive function
• Patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period
• History of abuse of a drug or alcohol within previous 2 years
• Patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks
• Patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.)
• History of hypersensitivity reaction to the main ingredient of the investigational drugs
• Patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)