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Trial record 25 of 58344 for:    Placebo

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

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).

Condition or disease Intervention/treatment Phase
Cognitive Impairment Stroke Drug: choline alfoscerate Drug: placebo (for choline alphoscerate) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363648


Locations
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Korea, Republic of
Seoul National University Bundang
Seongnam, Gyeoinggido, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-JOON BAE, Proffessor Seoul National University Bundang Hospital

Publications:
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Responsible Party: Hee-Joon Bae, Proffessor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01363648     History of Changes
Other Study ID Numbers: GLITTER-DW400
MOON KU HAN ( Registry Identifier: GLITTER )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Hee-Joon Bae, Seoul National University Hospital:
VCI-HS
stroke
choline alphoscerate

Additional relevant MeSH terms:
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Stroke
Dementia
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents