Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MOON KU HAN | Registry Identifier | GLITTER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To date, there are no approved treatments for vascular cognitive impairment (VCI) and the main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI development or progression. Several studies have reported cholinergic deficits in brain and cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical studies of Alzheimer's disease and VCI improved memory and attention impairments. The purpose of our study is to determine effectiveness of choline alphoscerate vs placebo in improving cognition in post-stroke patients with VCI-non dementia (VCI-ND).
Impaired brain cholinergic neurotransmission has a key role in the deterioration of cognitive functions in Alzheimer's disease and vascular cognitive impairment (VCI). These deficits, although are of different degree than those found in Alzheimer's disease, were suggested to be associated with VCI.To date, there are no approved treatments for vascular dementia(VaD)and the main therapeutic efforts in this field are aimed at controlling vascular risk factors for countering VaD development or progression.
There have also been several trials of cholinesterase inhibitors for treatment of VCI. Available data suggest some evidence of benefit of cholinesterase inhibitors in subcortical vascular dementia and vascular cognitive impairment.
Treated patients had modest benefits in cognition, attention, executive functioning and ability to perform instrumental activities of daily living, but the effect is too limited due to the small numbers of subjects examined and it is complex to establish the clinical relevance of these effects. The majority of clinical studies available on the effect of choline alphoscerate in neurodegenerative and cerebrovascular disorders were reviewed. A comparison of Alzheimer's disease assessment scale-cognitive subscale(ADAS-Cog)analysis with the results obtained on the same item in 4 trials with the cholinesterase inhibitor revealed a more positive trend with the cholinergic precursor choline alphoscerate than with this cholinesterase inhibitor.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choline alfoscerate | Experimental | choline alfoscerate 400mg, 3 times a day, for 12 weeks. |
|
| placebo (for choline alfoscerate ) | Placebo Comparator | placebo tablet, 3 times a day, for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| choline alfoscerate | Drug | Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change of K-TMT-e A of K-VCIHS-NP in the choline alfoscerate vs the placebo groups. | Primary analysis compares the change of K-TMT-e A of K-VCIHS-NP from the study entry 12 weeks later in the choline alfoscerate vs the placebo groups. | 12 weeks after taking drugs |
| Measure | Description | Time Frame |
|---|---|---|
| the change of other determinants of K-VCIHS-NP in the choline alfoscerate vs the placebo groups | secondary analysis compares the change of other determinants of K-VCIHS-NP from the study entry 12 weeks later in the choline alfoscerate vs the placebo groups. | 12 weeks after taking drugs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hee-JOON BAE, Proffessor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang | Seongnam | Gyeoinggido | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17331541 | Background | Parnetti L, Mignini F, Tomassoni D, Traini E, Amenta F. Cholinergic precursors in the treatment of cognitive impairment of vascular origin: ineffective approaches or need for re-evaluation? J Neurol Sci. 2007 Jun 15;257(1-2):264-9. doi: 10.1016/j.jns.2007.01.043. Epub 2007 Feb 28. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D005997 | Glycerylphosphorylcholine |
| ID | Term |
|---|---|
| D005994 | Glycerophosphates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo (for choline alphoscerate) | Drug | Pill manufactured to mimic choline alfoscerate 400mg tablet |
|
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D002241 | Carbohydrates |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D054709 | Lecithins |
| D010713 | Phosphatidylcholines |