- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04346862
Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
April 19, 2020 updated by: Hanmi Pharmaceutical Company Limited
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
636
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin-A Jung, Ph.D
- Phone Number: 82-2-410-9038
- Email: jajung@hanmi.co.kr
Study Locations
-
-
-
Incheon, Korea, Republic of
- Recruiting
- Catholic Kwandong University International St. Mary'S Hospital
-
Contact:
- Young-in Kim, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
|
Experimental: Acetyl-L-carnitine hydrochloride
|
The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interference score using K-CWST(Korean-Color Word Stroop Test)
Time Frame: 24 week
|
interference score is defined as 'the time required to test stage 2(Color-Word)' minus ''the time required to test stage 1(Word)
|
24 week
|
Montreal Cognitive Assessment Korean(MOCA-K)
Time Frame: 24 week
|
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.
|
24 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Korean Trail Making Test Elderly(K-TMT-e)
Time Frame: 24 week
|
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...).
|
24 week
|
EQ-5D
Time Frame: 24 week
|
EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
|
24 week
|
Clinical Global Impression -Improvement (CGI-I)
Time Frame: 24 week
|
CGI-I scored from 1 (very much improved) to 7 (very much worse).
|
24 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2016
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
April 13, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (Actual)
April 15, 2020
Study Record Updates
Last Update Posted (Actual)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 19, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Cerebrovascular Disorders
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Nootropic Agents
- Acetylcarnitine
Other Study ID Numbers
- HM-VASCA-401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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