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A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

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

About this trial

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

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 55 years
  2. Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria
  3. Diagnosed with mild cognitive impairment on SNSB
  4. Delayed recall score of SVLT ≤ "average -1.5 standard deviation"
  5. K-MMSE-2 score ≥ 24
  6. The CDR score 0.5, and the memory item score 0.5 or 1 point
  7. Patients with caregivers who are in regular contact, can visit together
  8. Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
  9. Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure.
  10. Written informed consent

Exclusion Criteria:

  1. 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.)
  2. Medication of dementia within the past three months
  3. Brain functional improvement medication in the past six weeks.
  4. Medication that may affect cognitive function during clinical trials
  5. No studies (no regular school entrance), illiteracy
  6. Significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (CT or MRI results performed within the past 12 months or during screening)
  7. 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
  8. Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.

Sites / Locations

  • Asan Medical Center Institutional Review Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline Alfoscerate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score

Secondary Outcome Measures

The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
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 weeks compared to baseline
The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline
The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity.
The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity.
The change of CDR-SB score at 48 weeks compared to baseline
CDR-SB calculates the CDR score as Sum of Boxes, in which case, the score in the six areas obtained by the evaluation is added as it is, and the range of the total score is 0 to 30, and the higher the score, the more severe the degree of dementia.

Full Information

First Posted
September 3, 2021
Last Updated
September 14, 2021
Sponsor
Chong Kun Dang Pharmaceutical
Collaborators
Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)
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1. Study Identification

Unique Protocol Identification Number
NCT05041790
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
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 Patients With Degenerative Mild Cognitive Impairment(ESCALADE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 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 patients with degenerative mild cognitive impairment.
Detailed Description
Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Choline Alfoscerate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Choline Alfoscerate
Intervention Description
Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
Primary Outcome Measure Information:
Title
The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline
Description
Definition of maintained/improved of cognitive function: decreased by more than or equal to 0 point of modified ADAS-Cog score
Time Frame
Baseline to 48 weeks
Secondary Outcome Measure Information:
Title
The proportion of subjects reduced by more than or equal to 0 points for modified ADAS-Cog score at 24 weeks compared to baseline
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 weeks 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
Description
The Modified ADAS-Cog 13 scale has a total of 85 points, and the higher the score, the higher the severity.
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The proportion of subjects increased by more than or equal to 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline
Description
K-MMSE-2 scale has a total of 30 points, and the lower the score, the higher the severity.
Time Frame
Baseline, 24 weeks, 48 weeks
Title
The change of CDR-SB score at 48 weeks compared to baseline
Description
CDR-SB calculates the CDR score as Sum of Boxes, in which case, the score in the six areas obtained by the evaluation is added as it is, and the range of the total score is 0 to 30, and the higher the score, the more severe the degree of dementia.
Time Frame
Baseline to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 55 years Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria Diagnosed with mild cognitive impairment on SNSB Delayed recall score of SVLT ≤ "average -1.5 standard deviation" K-MMSE-2 score ≥ 24 The CDR score 0.5, and the memory item score 0.5 or 1 point Patients with caregivers who are in regular contact, can visit together Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs) Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure. Written informed consent Exclusion Criteria: 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 three months Brain functional improvement medication in the past six weeks. Medication that may affect cognitive function during clinical trials No studies (no regular school entrance), illiteracy Significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (CT or MRI results performed within the past 12 months or during screening) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JaeHong Lee, MD
Phone
+82-2-3010-3446
Email
jhlee@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeHong Lee, MD
Organizational Affiliation
Asan Medical Center Institutional Review Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center Institutional Review Board
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JaeHong Lee, MD
Phone
+82-2-3010-3446
Email
jhlee@amc.seoul.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 Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

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