Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
What is being tested
Acetyl-L-Carnitine
+ Placebo of Acetyl-L-Carnitine
Drug
Who is being recruted
Mental Disorders+6
+ Brain Diseases
+ Central Nervous System Diseases
Over 50 Years
+21 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 4
Interventional
Study Start: April 2016
Summary
Principal SponsorDong-A ST Co., Ltd.
Last updated: April 14, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2016
Actual 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
Principal SponsorDong-A ST Co., Ltd.
Last updated: April 14, 2021
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 enrolled
Total 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.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer Disease
Criteria
6 inclusion criteria required to participate
12 <= K-MMSE(screening) <= 26
More than 50 Years
Patient taking donepezil(5mg or 10mg/day) more than 3 months
be able to perform examinations
Show More Criteria
15 exclusion criteria prevent from participating
Abnormal result of Vit.B12, Syphilis serology, TSH
Angina, Myocardial infarction, ischemia within six months
CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia
Head injury with sense of loss within six months
Show More Criteria
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
ExperimentalAcetyl-L-carnitine (DongA ST)
Group II
PlaceboPlacebo of Acetyl-L-carnitine (DongA ST)
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
Konkuk university medical center
Seoul, South KoreaOpen Konkuk university medical center in Google MapsCompletedOne Study Center