A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

NCT05041790

Mild Cognitive Impairment

UNKNOWN PHASE4

A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients

NCT02648906

Alzheimer Disease

UNKNOWN PHASE4

Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

NCT05383183

Alzheimer Disease

RECRUITING PHASE4

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

NCT01363648

Cognitive Impairment Stroke

COMPLETED PHASE4

The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

NCT03249259

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind (Participant, Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Choline Alfoscerate

Group Type EXPERIMENTAL

Choline Alfoscerate 400mg

Intervention Type DRUG

Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Placebo of Choline Alfoscerate

Group Type PLACEBO_COMPARATOR

Placebo of Choline Alfoscerate 400mg

Intervention Type DRUG

Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Choline Alfoscerate 400mg

Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Intervention Type DRUG

Placebo of Choline Alfoscerate 400mg

Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 50 years
* Patients with vascular cognitive impairment according to modified Fazekas scale grade 2\~3 and/or more than 3 of lacunar infarction in Supratentorial
* Patients with Clinical Deterioration Rating(CDR) score of 0.5
* Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less
* Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
* Written informed consent

Exclusion Criteria

* Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
* Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)
* Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)
* No studies (no regular school entrance), illiteracy
* Stroke within the past 3 months
* Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
* Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
* Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No