CITADEL: Effectiveness of CITicoline in Preventing Cognitive Decline After DELirium

Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled Trial

The aim of this study is to assess whether citicoline (TRAUSAN), a neuroprotective agent involved in membrane phospholipid synthesis and neurotransmission, can prevent or attenuate cognitive decline in older adults who develop perioperative delirium during hospitalization for proximal hip fracture. Delirium is a frequent and severe complication in this population and is associated with cognitive and functional deterioration, institutionalization, and mortality.

Participants will be randomly assigned (1:1) to receive citicoline 1000 mg/day for 6 months after discharge, or usual care. Cognitive and functional status will be evaluated at discharge and subsequently at 3 and 6 months follow-up visits.

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).