NCT05383183

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 630 (estimated)
• Sponsor: Daewoong Bio Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aging population is a characteristic feature of demographic trends in developed countries. Hence, Alzheimer's disease is recognized as one of today's major healthcare challanges, and its significance will increase even more as the longevity of the population increases. Pre-clinical investigations have suggested that association between ChE-Is (cholinesterase inhibitors) and the cholinergic precursor choline alfoscerate enhances cholinergic neurotransmission more effectively than single compounds alone. This clinical trial is designed to assess if combination of the ChE-I donepezil with choline alfoscerate has a more favorable clinical profile than monotherapy with donepezil alone.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Choline Alfoscerate 400mg	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2022-01-20
• Primary completion: 2025-06-30
• Completion: 2025-12-09
• First posted: 2022-05-20
• Last updated: 2024-03-21

Locations

4 sites across 1 country: South Korea