Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

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What is being tested

Acetyl-L-Carnitine

+ Placebo of Acetyl-L-Carnitine
Drug
Who is being recruted

Alzheimer Disease
+6

+ Mental Disorders
+ Brain Diseases
Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 4
Interventional
Study Start: April 2016
See protocol details

Summary

Principal SponsorDong-A ST Co., Ltd.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2016Actual date on which the first participant was enrolled.

A multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of Acetyl-L-carnitine in patient with Alzheimer's disease

Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease 
NCT02955706
Principal SponsorDong-A ST Co., Ltd.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
265 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Dementia
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Tauopathies
Criteria

Inclusion Criteria: * More than 50 Years * probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard * 12≤K-MMSE(screening)≤26 * be able to perform examinations * Patient taking donepezil(5mg or 10mg/day) more than 3 months * be able to visit to hospital with caregiver Exclusion Criteria: * possible or probable or definite vascular dementia according to NINDS-AIREN standard * CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia * Illiteracy * Patient taking galantamine, memantine, rivastigmine within three months * Patient taking brain enhancer, thyroid hormone within 4 weeks * Patient taking Central nervous system stimulant, Antipsychotic agent, anticholinergic agent within 2 weeks * at screenig blood test: AST, ALT≥ 3 X upper limit of normal range or Hb≤8g/dL or platelet\<100,000/mm3 or Serum creatinine ≥ 3 X upper limit of normal range * Abnormal result of Vit.B12, Syphilis serology, TSH * Severe Depression, Schizophrenia, Alcoholism, Drug addiction * Parkinson's disease (need to drug therapy) * Angina, Myocardial infarction, ischemia within six months * Head injury with sense of loss within six months * Patient taking other IP within three months * Hypersensitivity to IP * Sever Hearing problems or Visual impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Acetyl-L-carnitine (DongA ST)

TID
Group II
Placebo
Placebo of Acetyl-L-carnitine (DongA ST)

TID
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Konkuk university medical centerSeoul, Korea, Republic ofSee the location
CompletedOne Study Center
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