A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Choline Alfoscerate
|
Drug: Choline Alfoscerate 400mg
Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
|
| Placebo Comparator: Placebo of Choline Alfoscerate
|
Drug: Placebo of Choline Alfoscerate 400mg
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline [Baseline to 48 weeks]
Secondary Outcome Measures
- 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 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 [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 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
- 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
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Korea, Republic of | 05505 |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
- Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
Investigators
- Principal Investigator: Sun U Kwon, MD, PhD, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INFINITE-V (B78_03VCI2004)