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

NCT01363648 | Completed Phase 4 DMC

• 2 other identifiers: GLITTER-DW400MOON KU HAN
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Impairment; Stroke

Keywords

VCI-HS; stroke; choline alphoscerate

Outcome Measures

Primary Outcomes (1)

• the change of K-TMT-e A of K-VCIHS-NP in the choline alfoscerate vs the placebo groups.

  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.

  12 weeks after taking drugs

Secondary Outcomes (1)

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

  12 weeks after taking drugs

Study Arms (2)

Choline alfoscerate

EXPERIMENTAL

choline alfoscerate 400mg, 3 times a day, for 12 weeks.

Drug: choline alfoscerate

placebo (for choline alfoscerate )

PLACEBO COMPARATOR

placebo tablet, 3 times a day, for 12 weeks.

Drug: placebo (for choline alphoscerate)

Interventions

choline alfoscerate DRUG

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

Also known as: Gliatilin®

Choline alfoscerate

placebo (for choline alphoscerate) DRUG

Pill manufactured to mimic choline alfoscerate 400mg tablet

Also known as: placebo

placebo (for choline alfoscerate )

Eligibility Criteria

• Age: 25 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang

Seongnam, Gyeoinggido, 463-707, South Korea

Location

Related Publications (1)

• 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. doi: 10.1016/j.jns.2007.01.043. Epub 2007 Feb 28.

  PMID: 17331541 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Interventions

Glycerylphosphorylcholine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycerophosphates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Glycerophospholipids; Phosphatidic Acids; Phospholipids; Membrane Lipids; Lipids; Lecithins; Phosphatidylcholines

Study Officials

• Hee-JOON BAE, Proffessor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: May 29, 2011
• First Posted: June 1, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

KR (1)