RecruitingPhase 2NCT07804498

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

Sponsor

University of Milano Bicocca

Enrollment

122 participants

Start Date

Jun 3, 2026

Study Type

INTERVENTIONAL

Conditions

Cognitive Decline Delirium

Summary

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Citicoline for people with hip fracture, perioperative delirium, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCiticoline

Citicoline acts as a neuroprotective agent by supporting membrane integrity, modulating neurotransmission, and reducing oxidative stress and neuronal damage, with potential benefits on cognitive and functional recovery. However, no previous trials has investigated the effect of citicoline in preventing cognitive decline after delirium. Participants in the experimental arm of this study will receive citicoline (TRAUSAN) 1000 mg/day as an oral solution in single-dose 10 mL sachets (100 mg/mL), starting the day after hospital discharge, for a total duration of 6 months. 1 mL of citicoline solution contains 100 mg of citicoline (as sodium salt). Excipient(s) with known effects: 1 mL of Citicoline oral solution contains 200 mg of liquid sorbitol, 10 mg of glycerin, 1.8 mg of methyl parahydroxybenzoate, 0.42 mg of propyl parahydroxybenzoate, 1.4 mg of potassium sorbate, 0.012 mg of Ponceau 4R red, and other excipients.