Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetyl-L-carnitine hydrochloride 500mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Age between 55 and 85 years old
- Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 ~ 3
- Patients wtih a diagnosis of MCI
- MOCA-K of 23 or less
- Patients who provided a signed written informed consent form
Exclusion Criteria:
- Patiens who are uneducated or illiterate
- Patiens previously treated with dementia
- Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
- Patients with cognitive impairment due to diseases other than cerebrovascular disease
- Patients with severe depression, schizophrenia, alcoholism, and drug dependence
Sites / Locations
- Catholic Kwandong University International St. Mary'S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acetyl-L-carnitine hydrochloride
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Interference score using K-CWST(Korean-Color Word Stroop Test)
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
Montreal Cognitive Assessment Korean(MOCA-K)
MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better.
Secondary Outcome Measures
Korean Trail Making Test Elderly(K-TMT-e)
The K-TMT-e was composed of 2 parts: part A calls for the test-taker to connect randomly distributed numbers (1-25) on a test paper in ascending order (1->2->3...), whereas part B requires the test-taker to alternate numbers and letters (1->A->2->B...).
EQ-5D
EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Clinical Global Impression -Improvement (CGI-I)
CGI-I scored from 1 (very much improved) to 7 (very much worse).
Full Information
NCT ID
NCT04346862
First Posted
April 13, 2020
Last Updated
April 19, 2020
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT04346862
Brief Title
Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
Official Title
Phase IV Study to Evaluate the Effect of Improvement in Cognitive Impairment of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2016 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
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
The purpose of this study is to evaluate the efficacy of Acetyl-L-carnitine in patient with Mild Cognitive Impairment associated with chronic cerebrovascular disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
636 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetyl-L-carnitine hydrochloride
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-carnitine hydrochloride 500mg
Intervention Description
The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
Primary Outcome Measure Information:
Title
Interference score using K-CWST(Korean-Color Word Stroop Test)
Description
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
Time Frame
24 week
Title
Montreal Cognitive Assessment Korean(MOCA-K)
Description
MOCA-K included cognitive domains; attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. MOCA-K scored from 0 to 30. The higher the score, the better.
Time Frame
24 week
Secondary Outcome Measure Information:
Title
Korean Trail Making Test Elderly(K-TMT-e)
Description
The K-TMT-e was composed of 2 parts: part A calls for the test-taker to connect randomly distributed numbers (1-25) on a test paper in ascending order (1->2->3...), whereas part B requires the test-taker to alternate numbers and letters (1->A->2->B...).
Time Frame
24 week
Title
EQ-5D
Description
EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
24 week
Title
Clinical Global Impression -Improvement (CGI-I)
Description
CGI-I scored from 1 (very much improved) to 7 (very much worse).
Time Frame
24 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 55 and 85 years old
Patients with chronic cerebrovascular disease, who have modified Fazekas scale grade 2 ~ 3
Patients wtih a diagnosis of MCI
MOCA-K of 23 or less
Patients who provided a signed written informed consent form
Exclusion Criteria:
Patiens who are uneducated or illiterate
Patiens previously treated with dementia
Patients who received a nootropic agent or thyroid hormone within 4 weeks of visit 1
Patients with cognitive impairment due to diseases other than cerebrovascular disease
Patients with severe depression, schizophrenia, alcoholism, and drug dependence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-A Jung, Ph.D
Phone
82-2-410-9038
Email
jajung@hanmi.co.kr
Facility Information:
Facility Name
Catholic Kwandong University International St. Mary'S Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-in Kim, PhD
12. IPD Sharing Statement
Learn more about this trial
Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
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