Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
- Conditions
- Mild Cognitive Impairment
- Interventions
- Drug: Placebo
- Registration Number
- NCT04346862
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 636
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetyl-L-carnitine hydrochloride Acetyl-L-carnitine hydrochloride 500mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Montreal Cognitive Assessment Korean(MOCA-K) 24 week 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.
Interference score using K-CWST(Korean-Color Word Stroop Test) 24 week interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
- Secondary Outcome Measures
Name Time Method Korean Trail Making Test Elderly(K-TMT-e) 24 week 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...).
Clinical Global Impression -Improvement (CGI-I) 24 week CGI-I scored from 1 (very much improved) to 7 (very much worse).
EQ-5D 24 week EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Trial Locations
- Locations (1)
Catholic Kwandong University International St. Mary'S Hospital
🇰🇷Incheon, Korea, Republic of