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

Chong Kun Dang

Status and phase

Not yet enrolling

Phase 4

Conditions

Vascular Cognitive Impairment

Treatments

Drug: Placebo of Choline Alfoscerate 400mg

Drug: Choline Alfoscerate 400mg

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05050604

INFINITE-V (B78_03VCI2004)

Details and patient eligibility

About

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

Full 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

Enrollment

418 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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