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

Vascular Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05050604
• Other study ID #: INFINITE-V (B78_03VCI2004)
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Sun U Kwon, MD, PhD
• Phone: +82230103440
• Email: sukwon[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 418
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Vascular Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline		Baseline to 48 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline		Baseline, 24 weeks, 48 weeks
Secondary	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
Secondary	The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline		Baseline, 24 weeks, 48 weeks
Secondary	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
Secondary	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