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

What Was Tested

The trial (phase 4) is built around L-Carnitine.

It had two arms (groups): Acetyl-L-carnitine hydrochloride (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 636 planned participants were the target.

It was open to people of any sex aged from 55 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-01-26 with completion listed for 2020-06-30.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Interference score using K-CWST(Korean-Color Word Stroop Test) (time frame: 24 week). Montreal Cognitive Assessment Korean(MOCA-K) (time frame: 24 week).

It also tracked 3 secondary outcomes, for example Korean Trail Making Test Elderly(K-TMT-e) and EQ-5D.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 636 people.

With 636 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.