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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Cognitive Impairment
• Intervention / Treatment: Drug: Choline Alfoscerate 400mg; Drug: Placebo of Choline Alfoscerate 400mg

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 Type: Interventional
• Enrollment (Anticipated): 418
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sun U Kwon, MD, PhD; Phone Number: +82230103440; Email: sukwon@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
    • Contact: Sun U Kwon; Phone Number: +82230103440; Email: sukwon@amc.seooul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Choline Alfoscerate	Drug: Choline Alfoscerate 400mg; Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Placebo Comparator: Placebo of Choline Alfoscerate	Drug: Placebo of Choline Alfoscerate 400mg; Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline	Baseline to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline	ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale	Baseline to 24 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 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 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	K-MMSE-2: Korean version Mini-Mental State Exam-2	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 K-MoCA score at 24 to 48 weeks compared to baseline	K-MoCA: Korean-Montreal Cognitive Assessment	Baseline, 24 weeks, 48 weeks
The change of CDR-SB score at 48 weeks compared to baseline	CDR-SB: Sum of Boxes of Clinical Dementia Rating	Baseline to 48 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
• Investigators: Principal Investigator: Sun U Kwon, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Vascular Cognitive Impairment; Choline Alfoscerate
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: INFINITE-V (B78_03VCI2004)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No