A Phase 2 interventional study of Citicoline in Cognitive Decline and Delirium, sponsored by University of Milano Bicocca. Recruiting at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Milano Bicocca · Phase 2, Interventional, and Prevention
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 122 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Milano Bicocca is the lead sponsor of 126 studies on the registry; 47 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Excipients
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Participants randomized to the experimental arm will be administered Citicoline (TRAUSAN) at 1000 mg/day as an oral solution in single-dose 10 mL sachets (100 mg/mL), starting the day after hospital discharge and continued for 6 months (participants will receive a 3-month supply at enrollment and a further 3-month supply at the scheduled 3-month follow-up visit). Study drug accountability will be maintained through tracking of dispensed and returned sachets at follow-up visits. Participants will document daily intake, missed doses, treatment deviations, adverse events, and any changes in concomitant therapies in a diary (with the help of their caregivers), which will be reviewed at follow-up visits.
Drug: Citicoline
The control group will not receive any specific pharmacological treatment for cognitive decline prevention after delirium. Non-pharmacological interventions, such as those suggested by the HELP program to prevent delirium during hospitalization, will be equally provided in both the intervention and control groups as part of the in-hospital usual clinical care in all patients.
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.
Assess potential differences in cognitive profiles 6 months post-randomization among older adults hospitalized for proximal hip fractures with perioperative delirium, comparing the intervention arm (citicoline,TRAUSAN) to the control arm
Montreal Cognitive Assessment (MoCA) performed at discharge and at 6 months post-randomization
Time frame: 6 months
Evaluate differences in cognitive profiles in older adults hospitalized for proximal hip fractures at 0 (discharge), 3, and 6 months after randomization, comparing the intervention (citicoline, TRAUSAN) to the control arm.
Montreal Cognitive Assessment (MoCA) performed at discharge and at 3 and 6 months post-randomization
Time frame: Discharge, 3 months, and 6 months
Evaluate differences in functional profiles from 3 to 6 months post-randomization between the intervention (citicoline, TRAUSAN) and control arm.
Short Physical Performance Battery (SPPB), performed at 3 and 6 months post-randomization
Time frame: 3 months and 6 months
Evaluate differences in adverse events between the intervention and control groups during the 6-month follow-up period post-randomization.
Rates of adverse events (quantity/seriousness) during the 6-months follow-up after randomization
Time frame: 6 months
Plan to share: Undecided — Pseudonymized IPD may be shared with other researchers under reasonable written request to the Principal Investigator of this study.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 145 non-industry phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 64. This study's planned 18 months is below that.
Counting every sponsor, half of 186 studies reached it within 44 months; a quarter within 22 and three quarters within 62.
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University of Milano Bicocca →