Citicoline for Delirium | Cognitive decline | Hip fracture (proximal femur)

Inclusion criteria

• {"criterion_text":"- Individuals aged >65 years, who were admitted for a proximal hip fracture to the Orthogeriatric Unit and underwent hip fracture surgery (IRCCS San Gerardo dei Tintori Foundation, Monza)"}
• {"criterion_text":"- Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off > 4/12)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Prognosis quoad vitam ≥ 3 months"}
• {"criterion_text":"- Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule"}
• {"criterion_text":"- 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

• {"criterion_text":"- 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)"}
• {"criterion_text":"- Current therapy with citicoline"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Persistent in-hospital delirium (> 6 days or still present 24 hours prior to discharge)."}

Primary endpoints

• {"endpoint_text":"- The Montreal Cognitive Assessment (MoCA) performed before discharge and at 6 months post-randomization will allow to assess the primary objective.","definition_or_measurement_approach":"Assessment by Montreal Cognitive Assessment (MoCA) administered before discharge and at 6 months after randomization to compare cognitive profiles between intervention and control arms."}

Secondary endpoints

• {"endpoint_text":"- Montreal Cognitive Assessment (MoCA) performed before discharge and at 3 and 6months post-randomization","definition_or_measurement_approach":"MoCA administered before discharge and at 3 and 6 months post-randomization to evaluate changes over time."}
• {"endpoint_text":"- Short Physical Performance Battery (SPPB), performed at 3 and 6months post-randomization","definition_or_measurement_approach":"SPPB administered at 3 and 6 months post-randomization to assess functional profile."}
• {"endpoint_text":"- Rates of adverse events (quantity/seriousness) during the 6-months follow-up after randomization","definition_or_measurement_approach":"Recording and categorization of adverse events (frequency and seriousness) throughout the 6-month follow-up period after randomization."}

Italy

Earliest CTIS Part Ii Submission Date

07-10-2025

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

122

Primary sponsor

Full Name

Universita Degli Studi Di Milano Bicocca

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"PIAM pharmaceuticals S.P.A.","duties_or_roles":"Source of monetary support","organisation_type":"Commercial"}