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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Vascular Cognitive Impairment

Intervention / Treatment
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* Drug: Choline Alfoscerate 400mg
* Drug: Placebo of Choline Alfoscerate 400mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline Alfoscerate<br> | Drug: Choline Alfoscerate 400mg<br>* Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period<br>|
| Placebo Comparator: Placebo of Choline Alfoscerate<br> | Drug: Placebo of Choline Alfoscerate 400mg<br>* Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline |  | Baseline to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline | ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale | Baseline to 24 weeks | 
| The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline |  | Baseline, 24 weeks, 48 weeks | 
| The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline |  | Baseline, 24 weeks, 48 weeks | 
| The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline |  | Baseline, 24 weeks, 48 weeks | 
| The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline | K-MMSE-2: Korean version Mini-Mental State Exam-2 | Baseline, 24 weeks, 48 weeks | 
| The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline |  | Baseline, 24 weeks, 48 weeks | 
| The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline | K-MoCA: Korean-Montreal Cognitive Assessment | Baseline, 24 weeks, 48 weeks | 
| The change of CDR-SB score at 48 weeks compared to baseline | CDR-SB: Sum of Boxes of Clinical Dementia Rating | Baseline to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Cognitive Impairment, Choline Alfoscerate