Clincosm LogoSign in Get a demo

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

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04346862
Collaborator
(none)
636
Enrollment
1
Location
2
Arms
53.1
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetyl-L-carnitine hydrochloride 500mg
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
636 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2016
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acetyl-L-carnitine hydrochloride

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

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

Outcome Measures

Primary Outcome Measures

  1. Interference score using K-CWST(Korean-Color Word Stroop Test) [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)

  2. Montreal Cognitive Assessment Korean(MOCA-K) [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 Outcome Measures

  1. Korean Trail Making Test Elderly(K-TMT-e) [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...).

  2. EQ-5D [24 week]

    EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  3. Clinical Global Impression -Improvement (CGI-I) [24 week]

    CGI-I scored from 1 (very much improved) to 7 (very much worse).

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catholic Kwandong University International St. Mary'S Hospital Incheon Korea, Republic of

Sponsors and Collaborators

  • Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT04346862
Other Study ID Numbers:
  • HM-VASCA-401
First Posted:
Apr 15, 2020
Last Update Posted:
Apr 21, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cerebrovascular Disorders
Cognitive Dysfunction
Acetylcarnitine

Study Results

No Results Posted as of Apr 21, 2020