CITADEL: Effectiveness of CITicoline in Preventing Cognitive Decline After DELirium
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Milano Bicocca
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off ≥ 4/12)
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
Prognosis quoad vitam ≥ 3 months
Disqualifiers
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)
Current therapy with citicoline
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
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
Trial design
Design model
Parallel
Treatments tested in this trial
Citicoline
DrugCiticoline 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.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Experimental: Citicoline Intervention GroupExperimental treatment 1 intervention
Group B: No Intervention: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov