Vascular Cognitive Impairment
Conditions
Keywords
Vascular Cognitive Impairment, Choline Alfoscerate
Brief summary
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
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
Interventions
Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
DRUGPlacebo of Choline Alfoscerate 400mg
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Sponsors
Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline | Baseline to 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 24 weeks, 48 weeks | K-MMSE-2: Korean version Mini-Mental State Exam-2 |
| The change of K-MMSE-2 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 CDR-SB score at 48 weeks compared to baseline | Baseline to 48 weeks | CDR-SB: Sum of Boxes of Clinical Dementia Rating |
| 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 or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline | Baseline to 24 weeks | ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale |
| The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline | Baseline, 24 weeks, 48 weeks | K-MoCA: Korean-Montreal Cognitive Assessment |
Countries
South Korea
Contacts
Primary ContactSun U Kwon, MD, PhD
Outcome results
None listed