Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.

Official Title
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Phase IV Study to Evaluate the Effect of Improvement in Cognitive Impairment of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Acetyl-L-carnitine hydrochloride 500mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 55 and 85 years old Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2   3 Patients wtih a diagnosis of MCI MOCA-K of 23 or less Patients who provided a signed written informed consent form Exclusion Criteria: Patiens who are uneducated or illiterate Patiens previously treated with dementia Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1 Patients with cognitive impairment due to diseases other than cerebrovascular disease Patients with severe depression, schizophrenia, alcoholism, and drug dependence

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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: Acetyl-L-carnitine hydrochloride<br> | Drug: Acetyl-L-carnitine hydrochloride 500mg<br>* The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interference score using K-CWST(Korean-Color Word Stroop Test) | interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word) | 24 week | 
| Montreal Cognitive Assessment Korean(MOCA-K) | MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better. | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean Trail Making Test Elderly(K-TMT-e) | The K-TMT-e was composed of 2 parts: part A calls for the test-taker to connect randomly distributed numbers (1-25) on a test paper in ascending order (1->2->3...), whereas part B requires the test-taker to alternate numbers and letters (1->A->2->B...). | 24 week | 
| EQ-5D | EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | 24 week | 
| Clinical Global Impression -Improvement (CGI-I) | CGI-I scored from 1 (very much improved) to 7 (very much worse). | 24 week |