The Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia "GLITTER"

Completed

Phase 4 Results N/A

Trial Description

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).

Detailed Description

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.

Conditions

Interventions

  • Choine alphoscerate (alpha-glyceryl phosphoryl choline) Drug
    Other Names: Gliatilin® (choine alphoscerate)
    Intervention Desc: Participants were randomily assigned to twice-daily doses of 400mg choine alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®): or an identically appearing placebo for 12 weeks. The 400mg dose of gliatilin was chosen on information from prior clinical studies suggesting a dose-response relationship up to 400 mg.
    ARM 1: Kind: Experimental
    Label: Choline alfoscerate tablet
    Description: choline alfoscerate tablet 400mg, 3 times a day, for 12 weeks
  • Choline alfoscerate Drug
    Other Names: Gliatilin®
    Intervention Desc: Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)
    ARM 1: Kind: Experimental
    Label: Choline alfoscerate
    Description: choline alfoscerate 400mg, 3 times a day, for 12 weeks.
  • Placebo (for choline alphoscerate) Drug
    Other Names: placebo
    Intervention Desc: Pill manufactured to mimic choline alfoscerate 400mg tablet
    ARM 1: Kind: Experimental
    Label: placebo (for choline alfoscerate )
    Description: placebo tablet, 3 times a day, for 12 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary the change of K-TMT-e A of K-VCIHS-NP in the choline alfoscerate vs the placebo groups. 12 weeks after taking drugs No
Secondary the change of other determinants of K-VCIHS-NP in the choline alfoscerate vs the placebo groups 12 weeks after taking drugs No

Sponsors