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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 patients with degenerative mild cognitive impairment.
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline Alfoscerate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline Alfoscerate | Drug | Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline | Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline | 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 | |
|---|---|---|---|---|
| JaeHong Lee, MD | Contact | +82-2-3010-3446 | jhlee@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| JaeHong Lee, MD | Asan Medical Center Institutional Review Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center Institutional Review Board | Seoul | South Korea |
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| Placebo | Drug | Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire 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 weeks compared to baseline | Baseline, 24 weeks, 48 weeks |
| The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline | The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity. | Baseline, 24 weeks, 48 weeks |
| The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline | Baseline, 24 weeks, 48 weeks |
| The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline | K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity. | Baseline, 24 weeks, 48 weeks |
| The change of CDR-SB score at 48 weeks compared to baseline | CDR-SB calculates the CDR score as Sum of Boxes, in which case, the score in the six areas obtained by the evaluation is added as it is, and the range of the total score is 0 to 30, and the higher the score, the more severe the degree of dementia. | Baseline to 48 weeks |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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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