AuthorisedTherapeutic exploratory (Phase II)Interventional

Effectiveness of CITicoline (TRAUSAN) in preventing cognitive decline After DELirium in older adults with proximal hip fracture – The CITADEL randomized controlled trial

This research study, called CITADEL, is investigating a medicine called TRAUSAN (citicoline). It's designed for older adults who have experienced a hip fracture and became confused or disoriented, a condition known as delirium. The main goal is to find out if TRAUSAN can help reduce problems with memory, thinking, and mental clarity that can sometimes happen after delirium. We'll be comparing how well people's minds are working after taking TRAUSAN versus those who don't take it. Researchers will check people's thinking abilities when they leave the hospital and again six months later. This is an early stage study (Phase II) to see if TRAUSAN shows promise in this area.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita Degli Studi Di Milano Bicocca

Enrolment target

122

Start

13 Oct 2025

Cognitive profiles

What is this study about?

This study, called CITADEL, is focused on older adults who have had a hip fracture. Sometimes, after a big surgery or injury like a hip fracture, older people can become very confused or disoriented. Doctors call this 'delirium'. While delirium usually gets better, for some people, it can lead to longer-term problems with memory, thinking, and paying attention. These changes are sometimes called 'cognitive decline'.

The researchers want to see if a medicine called TRAUSAN, which is taken as an oral solution, can help prevent these thinking and memory problems from getting worse or even happening at all after someone has had delirium following a hip fracture. They believe TRAUSAN might help support brain health during this sensitive time.

To figure this out, some people in the study will receive TRAUSAN, and others won't. The study will carefully compare the two groups to see if TRAUSAN makes a difference in how well people's minds are working several months after their hip fracture. This is an important step to understand if TRAUSAN could be a useful treatment in the future to protect brain health in older adults after such an event.

Key takeaways

Study examines TRAUSAN for preventing thinking problems after hip fracture and delirium.
Aims to improve long-term mental clarity for older adults.
Involves simple memory and physical tests over six months.
Participation is voluntary, and you can withdraw anytime.
This is an early-stage study to explore potential benefits.

Who may be eligible?

This study is looking for older adults who have recently had a hip fracture. It's specifically for those who also experienced a period of confusion or disorientation, known as delirium, during their recovery.

The study welcomes both men and women. There are no specific age limits mentioned, meaning a wide range of older adults may be able to join.

More detailed information about who can and cannot join, such as other health conditions, would be discussed with the study team to ensure it's safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an older adult?
Have you recently had a hip fracture?
Did you experience confusion or disorientation (delirium) during your recovery?
Are you willing to take an oral liquid medicine?
Are you able to attend follow-up assessments over six months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might be given TRAUSAN (an oral solution, meaning you drink it) or a placebo (a dummy medicine with no active ingredients). This is decided randomly, like flipping a coin. You wouldn't know which one you're taking, nor would the doctors, to keep the results fair.

Over six months, you would have a few check-ups. Before you leave the hospital, and then again at three and six months after joining the study, you would have some simple tests. These tests mainly involve answering questions or doing small tasks to check your memory and thinking abilities. You might also have some tests to look at your physical ability, like how well you can move around.

The research team will also keep track of any health problems or side effects you might experience during the six-month period. The total time you would be involved in the study is six months.

Potential risks and benefits

Taking part in any study has possible benefits and risks. You might not benefit directly from taking part, but the information gained from this study could help future patients who experience similar problems after a hip fracture. While TRAUSAN is generally considered safe, there's always a chance of side effects, which the study team will monitor closely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your doctors will continue to look after you.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 'delirium'?

Delirium is when someone suddenly becomes confused, disoriented, or struggles to pay attention, often after a surgery or illness. It usually gets better but can sometimes affect thinking long-term.

What is TRAUSAN?

TRAUSAN is a medicine that comes as a drink. In this study, we're looking at whether it can help protect memory and thinking skills after delirium.

How long does the study last?

If you join, the study will involve follow-up for about six months.

Will I know if I'm getting the medicine or not?

No, this is a 'blinded' study, meaning neither you nor the doctors will know if you're taking TRAUSAN or a dummy medicine. This helps ensure fair results.

What kind of tests will I have?

You'll have simple memory and thinking tests, and some assessments of your physical movement, at different times over six months.