A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease

Inclusion Criteria:

1. Age of ≥50 to ≤85 as of the date of informed consent
2. Clinical diagnosis of probable Alzheimer's disease according to Diagnostic andStatistical Manual of Mental Disorders 4th Edition (DSM-IV) and National Institute ofNeurological and Communicative Disorders and Strokes; Alzheimer's disease and RelatedDisorders Association (NINCDS-ADRDA)
3. Mini Mental Status Examination (MMSE) score ≥10 to ≤26 at screening
4. Global Clinical Dementia Rating (CDR) score 0.5, 1 or 2 at screening
5. Capable of performing procedures for cognitive and other tests
6. Subject who meets any of the following as of the date of informed consent

• No past treatment with donepezil (naïve patient)
• Ongoing treatment with donepezil 10mg/day for the past 3 months
• Ongoing treatment with donepezil 5mg/day for the past 3 months

7. The subject or his/her representative must voluntarily decide to participate in thestudy and provide written informed consent.
8. The subject must have a reliable caregiver who regularly contacts the subject and isavailable to accompany the subject for on-site visits. (Note: A caregiver is definedas someone who has regular contact with the subject [i.e., an average of approximately 10 or more hours per week], must be able to oversee subject's compliance with thestudy treatment and to report on the patient's status and must be able to accompanythe subject to all study visits.)

Exclusion Criteria:

1. Possible, probable, or definite vascular dementia according to National Institute ofNeurological Disorders and Stroke/Association Internationale pur la Recherche etI'Enseignement en Neurosciences (NINDS-AIREN)
2. History and/or evidence (computed tomography [CT] or magnetic resonance imaging [MRI]findings obtained within the past 12 months or at screening) of other central nervoussystem (CNS) disorders (cerebrovascular disease, structural or developmental anomaly,epilepsy, or communicable, degenerative, or infectious/demyelinating CNS conditions)as a cause of dementia Note: >3 lacunar infarcts over 10 mm each, or severe whitematter disease equaling a rating of 3 on the age-related white matter changes (ARWMCscale) should be excluded in the study.
3. Illiteracy
4. Treatment with other anti-dementia drugs (galantamine, memantine, rivastigmine,tacrine), except donepezil, within the past 3 months from the date of informed consent
5. Treatment with any of the following drugs within the past 2 weeks from the date ofinformed consent

• CNS stimulants: methylphenidate, modafinil, pemoline, atomoxetine
• Typical antipsychotics: bromperidol, chlorpromazine, haloperidol
• Anticholinergics: atropine, glycopyrrolate, scopolamine, homatropine, ipratropium (short term [within 3 days] use of anticholinergics for the purpose ofantispasmodic action on the digestive system is permitted.)

6. Abnormal blood test findings as follows at the screening test:

• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥2.5 xupper limit of normal
• A serum creatinine level of ≥1.5 × ULN for the reference laboratory, or acalculated creatinine clearance by the Cockcroft-Gault equation of ≤50mL/min

7. Clinically significant abnormal vitamin B12, syphilis serology, or thyroid stimulatinghormone (TSH) test findings considered to contribute to the severity of dementia or tobe attributable to dementia Note:
8. Clinically significant untreated B12 should be excluded in the study. Subjectsare eligible if B12 deficiency is stable after the treatment.
9. If the subject has tested False positive for syphilis test, based on theinvestigator's judgment, further test can be performed to get the final result.
10. TSH >10mIU/L should be excluded in the study.
11. Diagnosis of serious mental disease based on DSM-5 criteria, including depressivedisorder,, schizophrenia, alcoholism, drug dependency, etc.
12. Parkinson's disease or parkinsonian syndrome
13. Clinically significant electrocardiogram (ECG) abnormalities at screening (heart rate <50 beats/min, atrial and ventricular conduction disorders such as 2nd degreeatrioventricular block, QTc interval >480ms)
14. History of unstable angina pectoris, myocardial infarction, transient ischemic attack,or coronary intervention including coronary bypass within the past 6 months from thedate of informed consent
15. History of severe traumatic head injury with loss of consciousness within the past 6months from the date of informed consent
16. Asthma or obstructive pulmonary disease requiring medication
17. Gastrointestinal disorders that may affect the absorption, distribution, andmetabolism of the study drug (e.g., inflammatory bowel disease, gastric or duodenalulcer, hepatic disease)
18. Uncontrolled diabetes mellitus (defined as HbA1c>9.0%)
19. Administration of other investigational products within 3 months prior to treatmentwith the investigational product (Day 0)
20. Hypersensitivity reactions to donepezil HCl, piperidine derivatives, or any of thecomponents of the study drug
21. Pregnant or lactating woman or woman of childbearing potential who does not agree touse an effective method of contraception. : Recommended effective methods of birth control include diaphragm plus spermicide ormale condom plus spermicide, oral contraceptive in combination with a second method,contraceptive implant, injectable contraceptive, indwelling intrauterine device,sexual abstinence, and vasectomized partners. The subject/investigator can discuss anyother best method that suits the subject.
22. Hereditary problems such as galactose intolerance, Lapp lactase deficiency, orglucose-galactose malabsorption
23. Human immunodeficiency virus (HIV) positive or Acquired Immune Deficiency Syndrome (AIDs)
24. History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completelyexcised and are considered cured, and cervical carcinoma in situ). Cancer survivorsnot on maintenance therapy that had no malignant disease history within the past 5years could be recruited.
25. Individual considered by the investigator to be ineligible for study participation forother reasons, including having a condition that may affect the assessment of studyresults