Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

Inclusion Criteria:

<Screening Inclusion Criteria>

1. 50 ≤ Age ≤ 85 at time of screening
2. Diagnosed as a probable Alzheimer Dementia patient according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and theAlzheimer's Disease and Related Disorders Association) criteria
3. 10 ≤ K-MMSE-2 score ≤ 26 at time of screening
4. 0.5 ≤ CDR score ≤ 2 at time of screening
5. Administration of donepezil 5 mg or 10 mg without dose change for at least 3 months attime of screening
6. Ability to walk or to move using a walking aid (i.e. senior walker, cane, orwheelchair)
7. Presence of a caregiver who regularly spends time with the patient and can accompanythe patient to hospital visits

• The caregiver must spend at least 8 hours per week with the patient
• The caregiver should be able to supervise trial compliance and report subjectstatus to the investigator

8. Sufficient visual acuity, hearing, language ability, motor function and comprehension,as judged by the investigator, to follow the examination procedure (auxiliary devicessuch as glasses and hearing aids are permitted)
9. Voluntarily decision to participate in this clinical trial from both the subject andthe subject's legal representative

<Randomization Inclusion Criteria>

1. 10 ≤ K-MMSE-2 score ≤ 26 at time of randomization
2. Compliance with donepezil ≥ 80% during run-in

Exclusion Criteria:

<Screening Exclusion Criteria>

1. Dementia due to other causes including:

• Probable vascular dementia according to NINDS-AIREN criteria
• Infection of the central nervous system (eg HIV, syphilis, etc.)
• Head trauma
• Creutzfeld-Jacob disease
• Pixie's disease
• Huntington's disease
• Parkinson's disease
• Drug addiction and/or Alcoholism

2. Patients with other major structural brain diseases (strategic cerebral infarction,subdural hematoma, traffic hydrocephalus, brain tumor) and/or evidence (CT or MRIresults performed within the past 12 months or at screening) as the cause of dementia (provided that (Excluding lacunar cerebral infarction with a diameter of less than 1cm in the area judged not to be related to cognitive function)
3. 3 ≤ New Rating Scale for ARWMC (Age-Related White Matter Changes) score within 12months of screening
4. Myocardial infarction, unstable angina pectoris, orthostatic hypotension orunexplained syncope within 12 months of screening, hospitalization for arrhythmia, ormoderate to severe congestive heart failure (NYHA class III or IV), clinicallyPatients with significant structural heart disease (valvular disease, hypertrophiccardiomyopathy)
5. Serious mental disorders such as severe depression, schizophrenia, alcoholism, anddrug dependence
6. History of malignant tumor within 5 years of screening. (However, enrollment isallowed if any of the following applies:)

• More than 5 years since completion of treatment for tumor
• Basal cell carcinoma, squamous cell carcinoma of the skin, or prostate cancer

7. Genetic problems such as galactose intolerance, lapp lactase deficiency or glucosegalactose malabsorption
8. Gastrointestinal diseases (inflammatory bowel disease, etc.) that may affect theabsorption of clinical investigational drugs
9. Administration of other dementia treatments (galantamine, rivastigmine, memantine)than donepezil within 3 months of screening
10. Administration of brain function improving drugs (citicoline, oxiracetam, piracetam,choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine, etc.)within 1 month of screening
11. Administration of dementia treatments, brain function improving agents, centralnervous system stimulants, anticholinergics, tricyclic antidepressants, classicantipsychotics, and hypnotics (excluding short-acting hypnotics) other thanexperimental drugs during trial period
12. Administration of atypical antipsychotics, anxiolytics, antidepressants (excepttricyclic antidepressants), thyroid hormones, short-acting hypnotics, hormonereplacement therapy, vitamin E, vitamin B12 supplements, antiparkinsonian drugs, andcholinergic drugs during trial period (However, enrollment is allowed if all of thefollowing apply:)

• Administration without any changes in dosage within 2 months of randomization
• Administration without any changes in dosage during trial period
• except for PRN drugs

13. Hypersensitivity to clinical investigational drugs (choline alfoscerate, donepezil),its components, or piperidine derivatives
14. Possibility of dementia due to abnormalities in vitamin B12, folic acid, and thyroidstimulating hormone (TSH) levels
15. Abnormalities in blood tests at screening:

• Liver dysfunction: AST or ALT ≥ 3 times the upper limit of normal range
• Renal dysfunction: Creatinine clearance* < 25 mL/min/1.73 m2 *MDRD Formula Creatinine clearance (mL/min/1.73m2)= 175 × {serum Creatinine (mg/dL)}- 1.154 × (Age)-0.203 × 0.742 (for female only)

16. Uncontrolled hypertension (SBP>180 mmHg)
17. Illitera
18. Pregnancy and lactation
19. In case of a woman, a patient who does not fall under any of the following:

• Menopause for at least 2 years at time of screening
• Contraceptive through surgical methods

20. Deemed inappropriate for enrollment by the investigator for other reasons <Randomization Exclusion Criteria>

1. Abnormalities in blood tests at time of randomization

• Liver dysfunction: AST or ALT ≥ 3 times the upper limit of normal range
• Renal dysfunction: Creatinine clearance* < 25 mL/min/1.73 m2 *MDRD Formula Creatinineclearance (mL/min/1.73m2)= 175 × {serum Creatinine (mg/dL)}- 1.154 × (Age)-0.203 × 0.742 (for female only) 2) Uncontrolled hypertension (SBP>180 mmHg) at the time ofrandomization 3) Administration of other investigational drugs within the past 3months from the time of randomization 4) Deemed inappropriate for enrollment by theinvestigator for other reasons