NCT05383183 (COALA) is a Phase 4 clinical trial of Choline Alfoscerate 400mg in Alzheimer Disease, sponsored by Daewoong Bio Inc..

Who is sponsoring NCT05383183?

NCT05383183 is sponsored by Daewoong Bio Inc..

What drugs are being tested in NCT05383183?

Interventions in NCT05383183: Choline Alfoscerate 400mg, Placebo.

What condition does NCT05383183 study?

NCT05383183 studies Alzheimer Disease.

Is NCT05383183 still recruiting?

NCT05383183 is currently status unknown. Last updated 21 March 2024.

Last reviewed 2024-03-21 · How we verify

NCT05383183: COALA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease

Status unknown Phase 4 Last updated 21 March 2024

What this trial tests

Phase 4 trial testing Choline Alfoscerate 400mg in Alzheimer Disease in 630 participants. Status unknown.

Timeline

20 January 2022

Primary endpoint
30 June 2025

9 December 2025

Quick facts

Lead sponsor	Daewoong Bio Inc.
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	630
Start date	20 January 2022
Primary completion	30 June 2025
Estimated completion	9 December 2025
Sites	4 locations across South Korea

Drugs / interventions tested

Choline Alfoscerate 400mg — full drug profile →
Placebo

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Daewoong Bio Inc. — full company profile →

Who can join

Adults 50 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Vitamin deficiencies and Alzheimer's disease: evidence and implications for supplementation.
Miteva MT, Laurenti D, Mattioli R, Di Risola D, et al · · 2026 · PMID 41769656 · DOI 10.3389/fnut.2026.1676497

Verify or expand the search:

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Other Daewoong Bio Inc. trials

Trials by the same sponsor.

NCT05219461 — Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05383183 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daewoong Bio Inc.
Last refreshed: 21 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05383183.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing