Study of Citicoline to Prevent Cognitive Decline After Delirium in Older Adults with Hip Fracture

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What is this study about?

This study focuses on older adults who have experienced delirium (a serious state of mental confusion) after hip fracture surgery. The research specifically looks at patients who also have chronic vascular encephalopathy (a brain condition caused by blood vessel problems). The study aims to determine if a medication called citicoline (TRAUSAN) can help prevent decline in thinking and memory abilities after experiencing delirium.

The treatment involves taking an oral solution of citicoline at a dose of 1000 mg per day. The medication will be given for a period of 6 months after the surgery. During this time, the study will monitor how well patients maintain their cognitive abilities, which includes functions like memory, attention, and problem-solving skills.

Throughout the study, participants will undergo various assessments of their mental function and physical abilities. The main evaluation will occur 6 months after starting the treatment using a comprehensive cognitive test called the Montreal Cognitive Assessment (MoCA). The study will also track any side effects that might occur during the treatment period.

1 Initial cognitive assessment

A cognitive test called Montreal Cognitive Assessment (MoCA) will be performed before discharge from the hospital.

This test evaluates different aspects of thinking and memory abilities.

2 Medication administration

The study medication is citicoline (TRAUSAN), which comes as an oral solution.

The solution is taken by mouth according to the prescribed schedule.

A caregiver may assist with taking the medication as needed.

3 Three-month follow-up

After 3 months, two assessments will be conducted:

Another Montreal Cognitive Assessment (MoCA) to check cognitive function

A Short Physical Performance Battery (SPPB) to evaluate physical abilities

4 Six-month follow-up

At 6 months, the final assessments will include:

A final Montreal Cognitive Assessment (MoCA) to evaluate cognitive function

Another Short Physical Performance Battery (SPPB) to assess physical abilities

Documentation of any side effects or health changes that occurred during the study period

5 Study completion

The study participation ends after completing the 6-month assessments

All health changes during the study period will be recorded and evaluated

Who Can Join the Study?

Must be over 65 years old and admitted to the hospital with a hip fracture near the joint that required surgery
Must have delirium (a serious condition causing confusion and reduced awareness) either before or after surgery, confirmed by a special assessment test called 4AT with a score higher than 4
Must have chronic vascular encephalopathy (long-term brain condition caused by problems with blood vessels in the brain), confirmed by medical records or brain scans
Must have a life expectancy of at least 3 months
Must have a caregiver (family member or professional) who can help with taking medications and attending scheduled visits
Must provide informed consent to participate in the study – this can be given by:
- The patient themselves
- Their legal guardian
- A witness (if the patient cannot sign but clearly shows they want to participate)

Who Cannot Join the Study?

Age below 65 years old
Presence of severe cognitive impairment (significant problems with memory, thinking, and decision-making) before the hip fracture
History of severe neurological conditions (serious diseases affecting brain and nerves) such as stroke or brain injury
Current diagnosis of severe psychiatric disorders (serious mental health conditions)
Inability to give informed consent
Known allergies to citicoline or other components of the study medication
Participation in other clinical trials within the last 30 days
Severe liver or kidney problems
Terminal illness with life expectancy less than 6 months
Inability to complete cognitive assessments due to language barriers or sensory impairments (problems with hearing or vision)
Planned discharge to a location where follow-up would not be possible
Use of medications that could interact with the study drug
Pregnancy or breastfeeding

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.08.2025

Trial locations

Citicoline (also known as TRAUSAN) is a brain-boosting supplement that helps protect and repair brain cells. It works as a neuroprotective agent that may help prevent cognitive decline, especially in older adults. This medication is commonly used to support brain function and may help improve memory and thinking abilities after periods of confusion or disorientation (delirium) that can occur after surgery.

Investigated diseases:

Cognitive disorder

Delirium – A serious disturbance in mental abilities that causes confused thinking and reduced awareness of the environment. It typically develops rapidly, over hours or days, and is characterized by fluctuating confusion, disorientation, and disrupted attention. People with delirium may experience hallucinations, changes in behavior, and disturbed sleep-wake cycles. The condition commonly occurs during hospitalization, especially in older adults after surgery or severe illness.

Cognitive Impairment – A condition where a person has trouble with mental processes such as memory, learning, concentration, and decision making. It ranges from mild to severe and can affect daily activities and social interactions. The condition can develop gradually and may fluctuate over time. It commonly affects older adults and can occur following medical procedures or hospitalizations.

Hip Fracture – A break in the upper portion of the femur (thigh bone) near where it connects to the hip joint. This type of injury typically occurs in the proximal (upper) part of the femur, affecting mobility and independence. The condition primarily affects older adults and can lead to temporary changes in cognitive function during the recovery period.

Trial ID:

2025-522306-21-00

Protocol code:

CITADEL

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Citicoline to Prevent Cognitive Decline After Delirium in Older Adults with Hip Fracture

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?