Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia

Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study

This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).

Inclusion Criteria:

• 50 - 90 years of age
• Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
• A diagnosis of probable Alzheimer's Disease, or mild to moderate AD determined by NIA-AA (National Institute on Aging and the Alzheimer's Association) criteria
• K-MMSE score of 12 - 26
• Global Clinical Dementia Rating (CDR) score of 0.5 - 2
• Patient taking 10 mg of donepezil per day for a minimum of 12 weeks with a stable dose, not taking other brain pills including choline alfoscerate for at least 2 weeks from screening. Drugs that are likely to affect cognition are permissible if the dose is regular and stable for at least 2 weeks before screening and if the treatment continues for the duration of the trial.

Exclusion Criteria:

• Subject suspected of dementia due to organic causes other than Alzheimer's type dementia
• Other degenerative brain diseases or major mental illnesses such as major depression, bipolar disorder, alcohol/substance abuse or dependence, delirium
• Hypersensitive to choline alfoscerate, donepezil hydrochloride, or piperidine derivatives or the components of this drug
• Subject who has contraindications as listed in the SPC of choline alfoscerate or donepezil hydrochloride
• Other than the above who is deemed to be ineligible to participate in the trial