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
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 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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