A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Mild Cognitive Impairment Patients With Cerebrovascular Disease

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease

Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment

Inclusion Criteria:

• Age ≥ 50 years
• Patients with vascular cognitive impairment according to modified Fazekas scale grade 2~3 and/or more than 3 of lacunar infarction in Supratentorial
• Patients with Clinical Deterioration Rating(CDR) score of 0.5
• Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
• Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
• Written informed consent

Exclusion Criteria:

• Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
• Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
• Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
• No studies (no regular school entrance), illiteracy
• Stroke within the past 3 months
• Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
• Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
• Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months