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

NCT05050604 | Unknown Phase 4

• 1 other identifier: INFINITE-V (B78_03VCI2004)
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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

Conditions

Vascular Cognitive Impairment

Keywords

Vascular Cognitive Impairment; Choline Alfoscerate

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 48 weeks

Secondary Outcomes (8)

• 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

• 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

  Baseline, 24 weeks, 48 weeks

Study Arms (2)

Choline Alfoscerate

EXPERIMENTAL

Drug: Choline Alfoscerate 400mg

Placebo of Choline Alfoscerate

PLACEBO COMPARATOR

Drug: Placebo of Choline Alfoscerate 400mg

Interventions

Choline Alfoscerate 400mg DRUG

Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Choline Alfoscerate

Placebo of Choline Alfoscerate 400mg DRUG

Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period

Placebo of Choline Alfoscerate

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies): collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Glycerylphosphorylcholine

Intervention Hierarchy (Ancestors)

Glycerophosphates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Glycerophospholipids; Phosphatidic Acids; Phospholipids; Membrane Lipids; Lipids; Lecithins; Phosphatidylcholines

Study Officials

• Sun U Kwon, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun U Kwon, MD, PhD

CONTACT

+82230103440; sukwon@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: September 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)