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| Name | Class |
|---|---|
| Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies) | UNKNOWN |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline Alfoscerate | Experimental |
| |
| Placebo of Choline Alfoscerate | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline Alfoscerate 400mg | Drug | Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline | ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale | Baseline to 24 weeks |
| The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun U Kwon, MD, PhD | Contact | +82230103440 | sukwon@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sun U Kwon, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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Double Blind (Participant, Investigator)
| Placebo of Choline Alfoscerate 400mg | Drug | Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period |
|
| 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 | K-MMSE-2: Korean version Mini-Mental State Exam-2 | Baseline, 24 weeks, 48 weeks |
| 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 | K-MoCA: Korean-Montreal Cognitive Assessment | Baseline, 24 weeks, 48 weeks |
| The change of CDR-SB score at 48 weeks compared to baseline | CDR-SB: Sum of Boxes of Clinical Dementia Rating | Baseline to 48 weeks |
| ID | Term |
|---|---|
| D005997 | Glycerylphosphorylcholine |
| ID | Term |
|---|---|
| D005994 | Glycerophosphates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D054709 | Lecithins |
| D010713 | Phosphatidylcholines |
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