Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease
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
1 other identifier
interventional
636
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedApril 21, 2020
April 1, 2020
4.4 years
April 13, 2020
April 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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)
24 week
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.
24 week
Secondary Outcomes (3)
Korean Trail Making Test Elderly(K-TMT-e)
24 week
EQ-5D
24 week
Clinical Global Impression -Improvement (CGI-I)
24 week
Study Arms (2)
Acetyl-L-carnitine hydrochloride
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic Kwandong University International St. Mary'S Hospital
Incheon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 15, 2020
Study Start
January 26, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
April 21, 2020
Record last verified: 2020-04