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

NCT05041790 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2021-09-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)

    collaborator UNKNOWN
  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • JaeHong Lee, MD · Asan Medical Center Institutional Review Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041790 on ClinicalTrials.gov