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A

Asan Medical Center | Clinical Trial Center

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

C

Chong Kun Dang

Status and phase

Not yet enrolling
Phase 4

Conditions

Vascular Cognitive Impairment

Treatments

Drug: Choline Alfoscerate 400mg
Drug: Placebo of 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

418 participants in 2 patient groups, including a placebo group

Choline Alfoscerate
Experimental group
Treatment:
Drug: Choline Alfoscerate 400mg
Placebo of Choline Alfoscerate
Placebo Comparator group
Treatment:
Drug: Placebo of Choline Alfoscerate 400mg

Trial contacts and locations

1

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Central trial contact

Sun U Kwon, MD, PhD

Data sourced from clinicaltrials.gov

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