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

NCT01363648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2013-10-14

No results posted yet for this study

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).

Conditions

Interventions

DRUG

choline alfoscerate

Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)

DRUG

placebo (for choline alphoscerate)

Pill manufactured to mimic choline alfoscerate 400mg tablet

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hee-JOON BAE, Proffessor · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363648 on ClinicalTrials.gov