Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease
Trial Parameters
Brief Summary
The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone.
Eligibility Criteria
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 the Alzheimer'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 at time of screening 6. Ability to walk or to move using a walking aid (i.e. senior walker, cane, or wheelchair) 7. Presence of a caregiver who regularly spends time with the patient and can accompany the 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 subject status to the investigator 8. Sufficient visual acuity, hearing, language ability, motor function and comprehension