Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Drug: Acetyl-L-carnitine hydrochloride 500mg
    • The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
  • Drug: Placebo
    • The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks

Arms, Groups and Cohorts

  • Experimental: Acetyl-L-carnitine hydrochloride
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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.

Secondary Measures

  • 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…).
  • EQ-5D
    • Time Frame: 24 week
    • EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
  • Clinical Global Impression -Improvement (CGI-I)
    • Time Frame: 24 week
    • CGI-I scored from 1 (very much improved) to 7 (very much worse).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hanmi Pharmaceutical Company Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jin-A Jung, Ph.D, 82-2-410-9038, jajung@hanmi.co.kr

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