The Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia (GLITTER)
|ClinicalTrials.gov Identifier: NCT01363648|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : October 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment Stroke||Drug: choline alfoscerate Drug: placebo (for choline alphoscerate)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase IV Trial for an Evaluation of the Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Choline alfoscerate
choline alfoscerate 400mg, 3 times a day, for 12 weeks.
Drug: choline alfoscerate
Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)
Other Name: Gliatilin®
Placebo Comparator: placebo (for choline alfoscerate )
placebo tablet, 3 times a day, for 12 weeks.
Drug: placebo (for choline alphoscerate)
Pill manufactured to mimic choline alfoscerate 400mg tablet
Other Name: placebo
- the change of K-TMT-e A of K-VCIHS-NP in the choline alfoscerate vs the placebo groups. [ Time Frame: 12 weeks after taking drugs ]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.
- the change of other determinants of K-VCIHS-NP in the choline alfoscerate vs the placebo groups [ Time Frame: 12 weeks after taking drugs ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363648
|Korea, Republic of|
|Seoul National University Bundang|
|Seongnam, Gyeoinggido, Korea, Republic of, 463-707|
|Principal Investigator:||Hee-JOON BAE, Proffessor||Seoul National University Bundang Hospital|