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

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

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

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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