Can citicoline help prevent cognitive decline after delirium in older adults with hip fracture?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 trial, older adults who experience delirium around hip fracture surgery are randomized to receive citicoline 1000 mg daily for six months after discharge or usual care. Cognitive and functional outcomes will be measured at discharge and at 3 and 6 months follow-up to see if citicoline helps preserve function. The study focuses on preventing subsequent cognitive decline in a high-risk perioperative delirium population. Enrollment is at a single center in Monza, Italy, led by the University of Milano Bicocca.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals aged ≥65 who were admitted for a proximal hip fracture to the Orthogeriatric Unit and underwent hip fracture surgery (IRCCS San Gerardo dei Tintori Foundation, Monza)
2. Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off ≥ 4/12)
3. Diagnosis of chronic vascular encephalopathy (corroborated by clinical documentation or previous cerebral imaging), i.e. evidence of neurological and cognitive disorder resulting from cerebrovascular accidents
4. Prognosis quoad vitam ≥ 3 months
5. Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
6. Informed consent, freely granted from the participant or from his/her legal guardian (or from an impartial witness in cases where the patient is unable to sign but clearly expresses the will to participate), and acquired before the randomization.

Exclusion Criteria:

1. Diagnosis of severe dementia (defined by medical clinical records or by the presence of an AD8 score ≥6 and a Global Deterioration Scale score ≥6)
2. Current therapy with citicoline
3. Any contraindications to citicoline (TRAUSAN), including allergy to acetylsalicylic acid or excipients contained in the drug, previous adverse reactions to citicoline, hypertonia of the parasympathetic nervous system, low-sodium diet
4. Clinical conditions or situations other than the condition being studied, which in the opinion of the researchers could interfere with the study or not allow optimal participation
5. Persistent in-hospital delirium (≥ 6 days or still present 24 hours prior to discharge).

Where it's running

• IRCCS San Gerardo dei Tintori Foundation
  Monza, Monza E Brianza, Italy Recruiting

Study contacts

• Principal investigator: Giuseppe Bellelli, Medical doctor, full professor — University of Milano-Bicocca, IRCCS San Gerardo dei Tintori Foundation
• Study coordinator: Maria Cristina Ferrara, Medical doctor and PhD
• Email: mariacristina.ferrara@unimib.it
• Phone: +39 0392339719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.