Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

13 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Citicoline (Trausan) – A brain-boosting medication administered orally that belongs to the class of nootropics and psychostimulants. This substance naturally occurs in brain cells and plays a crucial role in maintaining cognitive function by supporting the formation of cell membranes and neurotransmitter production. Citicoline is primarily used to improve cognitive performance, memory, and mental clarity, particularly in elderly patients recovering from delirium or brain injury, and it works by enhancing brain cell repair and increasing levels of important neurotransmitters in the brain. The medication has shown promising results in clinical studies for preventing cognitive decline and supporting brain function recovery, especially in older adults following medical procedures or trauma.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2025-522306-21-00Protocol codeCITADELEstimated enrolment122 patientsSponsorUniversita Degli Studi Di Milano Bicocca

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).