IRCCS San Gerardo dei Tintori Foundation
Monza, Monza E Brianza, 20900, Italy
Location status: Recruiting
NCT Number: NCT07804498
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 2
Monza, Monza E Brianza, 20900, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) performed at discharge and at 6 months post-randomization
Time frame: Discharge, 3 months, and 6 months
Montreal Cognitive Assessment (MoCA) performed at discharge and at 3 and 6 months post-randomization
Time frame: 3 months and 6 months
Short Physical Performance Battery (SPPB), performed at 3 and 6 months post-randomization
Time frame: 6 months
Rates of adverse events (quantity/seriousness) during the 6-months follow-up after randomization
Contact information is provided by the study sponsor or research team.
University of Milano Bicocca
Other
Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled Trial
Acronym: CITADEL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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