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

Phase 4

Not yet recruiting

• Conditions: Vascular Cognitive Impairment
• Interventions: Drug: Placebo of Choline Alfoscerate 400mg; Drug: Choline Alfoscerate 400mg

• Registration Number: NCT05050604
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 418

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo of Choline Alfoscerate	Placebo of Choline Alfoscerate 400mg	-
Choline Alfoscerate	Choline Alfoscerate 400mg	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
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	K-MMSE-2: Korean version Mini-Mental State Exam-2
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline	Baseline, 24 weeks, 48 weeks	K-MoCA: Korean-Montreal Cognitive Assessment
The change of CDR-SB score at 48 weeks compared to baseline	Baseline to 48 weeks	CDR-SB: Sum of Boxes of Clinical Dementia Rating

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of