NCT05050604

A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 418 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 50 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 Mild Cognitive Impairment Patients with Cerebrovascular Disease

Detailed description

Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment

Conditions

• Vascular Cognitive Impairment

Interventions

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

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2021-09-20
• Last updated: 2021-09-20

Locations

1 site across 1 country: South Korea