Mild Cognitive Impairment
Conditions
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.
Interventions
DRUGAcetyl-L-carnitine hydrochloride 500mg
The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
DRUGPlacebo
The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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...). |
| EQ-5D | 24 week | EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Clinical Global Impression -Improvement (CGI-I) | 24 week | CGI-I scored from 1 (very much improved) to 7 (very much worse). |
Countries
South Korea
Contacts
Primary ContactJin-A Jung, Ph.D
Outcome results
None listed