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GLITTER

CompletedPhase 4

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

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

Asset

Choline alfoscerate

Listed sites

1

Recruiting sites

-

Enrollment

222

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Age 25-84•MRI contraindications excluded

Primary endpoint

•K-TMT-e A of K-VCIHS-NP in the choline alfoscerate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGLITTER-DW400
RegistryMOON KU HANGLITTER
NCT IDNCT01363648

Timeline

Milestones

Study start2010-11 (month precision)
Study first posted2011-06-01estimated
Primary completion2013-03actual (month precision)
Study completion2013-03actual (month precision)
Last update posted2013-10-14estimated

Assets

Drug assets

Choline alfoscerate

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age25 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

the change of other determinants of K-VCIHS-NP in the choline alfoscerate vs the placebo groups

Time frame:12 weeks after taking drugs

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.