NCT07804498 CITADEL: Effectiveness of CITicoline in Preventing Cognitive Decline After DELirium
| NCT ID | NCT07804498 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Milano Bicocca |
| Condition | Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2027-12-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 122 participants in total. It began in 2026-06-03 with a primary completion date of 2027-12-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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) 2. Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off ≥ 4/12) 3. 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 4. Prognosis quoad vitam ≥ 3 months 5. Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule 6. 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: 1. 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) 2. Current therapy with citicoline 3. 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 4. 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 5. Persistent in-hospital delirium (≥ 6 days or still present 24 hours prior to discharge).
Contact & Investigator
Giuseppe Bellelli, Medical doctor, full professor
PRINCIPAL INVESTIGATOR
University of Milano-Bicocca, IRCCS San Gerardo dei Tintori Foundation
Frequently Asked Questions
Who can join the NCT07804498 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07804498 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07804498 currently recruiting?
Yes, NCT07804498 is actively recruiting participants. Contact the research team at mariacristina.ferrara@unimib.it for enrollment information.
Where is the NCT07804498 trial being conducted?
This trial is being conducted at Monza, Italy.
Who is sponsoring the NCT07804498 clinical trial?
NCT07804498 is sponsored by University of Milano Bicocca. The principal investigator is Giuseppe Bellelli, Medical doctor, full professor at University of Milano-Bicocca, IRCCS San Gerardo dei Tintori Foundation. The trial plans to enroll 122 participants.