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

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Acetyl-L-carnitine hydrochloride 500mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04346862

HM-VASCA-401

Details and patient eligibility

About

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.

Enrollment: 636 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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636 participants in 2 patient groups, including a placebo group

Acetyl-L-carnitine hydrochloride

Experimental group

Treatment:

Drug: Acetyl-L-carnitine hydrochloride 500mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo