UnknownPhase 4

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

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

Lead sponsor

Chong Kun Dang Pharmaceutical

Asset

Choline alfoscerate

Listed sites

Recruiting sites

Enrollment

418

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•Age ≥50

Primary endpoint

•Proportion of subjects whose cognitive function is maintained/improved

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDINFINITE-V (B78_03VCI2004)

NCT IDNCT05050604

Timeline

Milestones

Study start2021-09estimated (month precision)

Study first posted2021-09-20actual

Last update posted2021-09-20actual

Primary completion2024-11estimated (month precision)

Study completion2024-11estimated (month precision)

Assets

Drug assets

Choline alfoscerate

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot 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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

9 endpoints

Primary/protocol endpoint

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

Time frame:Baseline to 48 weeks

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline

Time frame:Baseline to 24 weeks

ADAS-Cog

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline