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

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ClinicalTrials.gov Identifier: NCT01363648
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Hee-Joon Bae, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE May 29, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date October 14, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01363648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia
Official Title  ICMJE 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
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Impairment
  • Stroke
Intervention  ICMJE
  • Drug: choline alfoscerate
    Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)
    Other Name: Gliatilin®
  • Drug: placebo (for choline alphoscerate)
    Pill manufactured to mimic choline alfoscerate 400mg tablet
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Choline alfoscerate
    choline alfoscerate 400mg, 3 times a day, for 12 weeks.
    Intervention: Drug: choline alfoscerate
  • Placebo Comparator: placebo (for choline alfoscerate )
    placebo tablet, 3 times a day, for 12 weeks.
    Intervention: Drug: placebo (for choline alphoscerate)
Publications * 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. Epub 2007 Feb 28. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
222
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients were outpatients (age 25 to 84 years) with vascular cognitive impairment that does not fulfill dementia criteria (vascular cognitive impairment, no dementia(CIND)), had been stroke free for 90 days, together with clinical and radiological evidence of stroke and can perform K-TMT-e A. Cognitive impairment did not meet the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition (DSM-III-R) criteria for dementia (ie, they did not have both memory impairment and other cognitive impairment that caused functional deficits).

Exclusion Criteria:

  • Exclusion criteria included clinical or radiological evidence of neurodegenerative disorders other than VCI. Patients with major depression or other psychiatric disorders (according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) were excluded. Patients who had experienced a myocardial infarction within 3 months of enrollment were excluded (although these patients could be reconsidered for inclusion once 3 months had elapsed), as were those with clinically relevant hepatic, pulmonary, gastrointestinal, or life-threatening disease. Additional reasons for exclusion included pregnancy, a history of alcohol or drug abuse, and contraindications for MRI studies. Medications that affect the cognitive function were not permitted within the last 30 days. Patients were not permitted to receive anticholinergic drugs or cholinergic agents other than gliatilin during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363648
Other Study ID Numbers  ICMJE GLITTER-DW400
MOON KU HAN ( Registry Identifier: GLITTER )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hee-Joon Bae, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hee-JOON BAE, Proffessor Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP