RecruitingPhase 4NCT05383183

Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Patients With Mild to Moderate Alzheimer's Disease


Sponsor

Daewoong Bio Inc.

Enrollment

630 participants

Start Date

Jan 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine whether combination of donepezil, a cholinesterase inhibitor, with choline alfoscerate has a more favourable clinical profile than monotherapy with donepezil alone.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a supplement called choline alfoscerate — a natural compound that supports brain function — can improve memory and thinking when added to the standard Alzheimer's medication donepezil. It targets people with mild to moderate Alzheimer's disease who are already stable on donepezil. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with probable Alzheimer's disease - You score between 10 and 26 on a standard memory test (K-MMSE-2) - You have been taking donepezil 5 mg or 10 mg at a stable dose for at least 3 months - You have a caregiver who spends at least 8 hours per week with you and can accompany you to visits - You are able to walk or move with a walking aid **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's (such as stroke, brain injury, or Parkinson's disease) - You have had a heart attack or unstable heart condition in the past year - You have severe depression, schizophrenia, or active substance use disorder - You have been diagnosed with cancer in the last 5 years (some exceptions apply) - You are currently taking another dementia treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCholine Alfoscerate 400mg

Oral administration

DRUGPlacebo

Oral administration


Locations(4)

The Catholic University of Korea Seoul ST.MARY'S Hospital

Seoul, South Korea

Changwon Fatima Hospital

Changwon, South Korea

CHA Bundang Medical Center

Seongnam, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

View Full Details on ClinicalTrials.gov

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NCT05383183


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