search
Back to results

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

Primary Purpose

Vascular Cognitive Impairment

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Choline Alfoscerate 400mg
Placebo of Choline Alfoscerate 400mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Cognitive Impairment focused on measuring Vascular Cognitive Impairment, Choline Alfoscerate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline Alfoscerate

Placebo of Choline Alfoscerate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
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
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
K-MoCA: Korean-Montreal Cognitive Assessment
The change of CDR-SB score at 48 weeks compared to baseline
CDR-SB: Sum of Boxes of Clinical Dementia Rating

Full Information

First Posted
September 10, 2021
Last Updated
September 10, 2021
Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
search

1. Study Identification

Unique Protocol Identification Number
NCT05050604
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment
Keywords
Vascular Cognitive Impairment, Choline Alfoscerate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind (Participant, Investigator)
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Choline Alfoscerate
Arm Type
Experimental
Arm Title
Placebo of Choline Alfoscerate
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Choline Alfoscerate 400mg
Intervention Description
Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Intervention Type
Drug
Intervention Name(s)
Placebo of Choline Alfoscerate 400mg
Intervention Description
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
Primary Outcome Measure Information:
Title
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Time Frame
Baseline to 48 weeks
Secondary Outcome Measure Information:
Title
The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
Description
ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
Time Frame
Baseline to 24 weeks
Title
The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
Description
K-MMSE-2: Korean version Mini-Mental State Exam-2
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline
Description
K-MoCA: Korean-Montreal Cognitive Assessment
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of CDR-SB score at 48 weeks compared to baseline
Description
CDR-SB: Sum of Boxes of Clinical Dementia Rating
Time Frame
Baseline to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun U Kwon, MD, PhD
Phone
+82230103440
Email
sukwon@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun U Kwon, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun U Kwon
Phone
+82230103440
Email
sukwon@amc.seooul.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs