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

Chong Kun Dang Pharmaceutical1 site in 1 country418 target enrollmentSeptember 2021

ConditionsVascular Cognitive Impairment

InterventionsCholine Alfoscerate 400mg Placebo of Choline Alfoscerate 400mg

DrugsCholine Alfoscerate 400mg Placebo of Choline Alfoscerate 400mg

Overview

Phase: Phase 4
Intervention: Choline Alfoscerate 400mg
Conditions: Vascular Cognitive Impairment
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 418
Locations: 1
Primary Endpoint: The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 2021

End Date

November 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Choline Alfoscerate

Intervention: Choline Alfoscerate 400mg

Placebo of Choline Alfoscerate

Intervention: Placebo of Choline Alfoscerate 400mg

Outcomes

Primary Outcomes

The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline

Time Frame: Baseline to 48 weeks

Secondary Outcomes

The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline(Baseline, 24 weeks, 48 weeks)
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline(Baseline to 24 weeks)
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
The change of CDR-SB score at 48 weeks compared to baseline(Baseline to 48 weeks)
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)
The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline(Baseline, 24 weeks, 48 weeks)