Clinical trial NCT05050604: A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vascular Cognitive Impairment
Keywords: Vascular Cognitive Impairment
Choline Alfoscerate
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
First posted: 2021-09-20
Enrollment: 418
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
timeFrame: Baseline to 48 weeks
Secondary outcomes:
measure: The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
timeFrame: Baseline to 24 weeks
measure: The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
timeFrame: Baseline, 24 weeks, 48 weeks
measure: The change of CDR-SB score at 48 weeks compared to baseline
timeFrame: Baseline to 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sun U Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: