NCT05041790

A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment(ESCALADE)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 418 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in patients with degenerative mild cognitive impairment.

Detailed description

Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Choline Alfoscerate	Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
DRUG	Placebo	Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-09-13
• Last updated: 2021-09-20

Locations

1 site across 1 country: South Korea