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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04346862
• Other study ID #: HM-VASCA-401
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Jin-A Jung, Ph.D
• Phone: 82-2-410-9038
• Email: jajung[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 636
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Catholic Kwandong University International St. Mary'S Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Korean Trail Making Test Elderly(K-TMT-e)	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
Secondary	EQ-5D	EQ-5D included 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	24 week
Secondary	Clinical Global Impression -Improvement (CGI-I)	CGI-I scored from 1 (very much improved) to 7 (very much worse).	24 week