Rare diseases
Investigational molecules
Locations
Citicoline is the generic name for cytidine-5′-diphosphocholine (CDP-choline), a substance that is identical to a natural molecule inside cells that acts as a precursor of the phospholipid phosphatidylcholine.[2] The body makes citicoline from choline, a nutrient found in the diet.[3] In the European trial registry, citicoline is classified as a chemically synthesised substance in the nervous system therapeutic area (ATC code N06BX06).[1] It is already authorised as a medicine in Italy under the trade name TRAUSAN 1000 mg oral solution, held by PIAM FARMACEUTICI SPA.[1]
After being taken by mouth, citicoline is believed to be quickly broken down into cytidine and choline. These two building blocks enter the brain separately and are used inside brain cells to rebuild CDP-choline.[2] The body needs citicoline to make important brain chemicals, including dopamine, norepinephrine, and acetylcholine, which send messages between nerve cells.[3] In laboratory models of brain ischaemia and trauma, citicoline has repeatedly shown neuroprotective activity, meaning it appears to help protect brain cells from damage.[2]
In the registered trial, citicoline is given as an oral solution containing 1000 mg per dose.[1] The pharmaceutical form recorded in the trial registry is an oral solution, and the route of administration is oral, meaning it is taken by mouth.[1] The same product, TRAUSAN 1000 mg oral solution, is the authorised medicine in Italy.[1]
One clinical trial of citicoline is registered in the EU Clinical Trials Information System. The study, called CITADEL, is a Phase 2 interventional trial that plans to enrol 122 participants.[1] The trial is currently authorised, meaning it has received approval to proceed.[1]
The trial focuses on older adults hospitalised for proximal hip fractures who experienced perioperative delirium. It compares an intervention arm receiving citicoline (TRAUSAN) with a control arm.[1] The primary outcome is the Montreal Cognitive Assessment (MoCA) score, a standard test of cognitive function, measured before discharge from hospital and again at 6 months after randomisation.[1]
The main question the trial asks is whether there are differences in cognitive profiles 6 months after randomisation between people who received citicoline and those in the control arm.[1]
Common side effects of citicoline reported in dietary supplement use include anxiety, restlessness, and an upset stomach.[3] The available sources do not provide a separate list of serious side effects for citicoline.
What condition is citicoline being tested for in the registered trial? The registered Phase 2 trial is testing citicoline for cognitive decline after delirium in older adults who had surgery for a proximal hip fracture.[1]
Who can take part in the citicoline trial? The trial enrols older adults who were hospitalised for proximal hip fractures and experienced perioperative delirium.[1]
What is the phase and status of the citicoline trial? The trial is a Phase 2 interventional study and is currently authorised, with a planned enrolment of 122 participants.[1]
What does the trial measure? The main measure is the Montreal Cognitive Assessment (MoCA) score, taken before discharge and at 6 months after randomisation.[1]
Is citicoline already an authorised medicine? Yes, citicoline is authorised as a medicine in Italy under the trade name TRAUSAN 1000 mg oral solution.[1]
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
