Cognitive DeclinePhase 2CITADELNCT07804498
CITADEL: Effectiveness of CITicoline in Preventing Cognitive Decline After DELirium
A Phase 2 study testing Citicoline in people with Cognitive Decline and Delirium, run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline, Delirium
- What is being tested?
- Citicoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2026to 5 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
- 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.
Who cannot join
- 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
- Persistent in-hospital delirium (≥ 6 days or still present 24 hours prior to discharge).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Gerardo dei Tintori Foundation
Monza, Monza E Brianza, 20900
Maria Cristina Ferrara, Medical doctor, PhD, +39 0392339719, mariacristina.ferrara@unimib.it
About this study
Official title: Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled 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.
- Conditions
- Cognitive Decline, Delirium
- Being tested
- Citicoline
- Keywords
- Cognitive decline, Delirium, Citicoline, Hip fracture
- Medical subject headings
- Cognitive Dysfunction, Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Citicoline Intervention Group | Experimental | 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. Receives: Drug: Citicoline |
| No Intervention: Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start3 Jun 2026
- Primary completion5 Dec 2027 (estimated)
- Study completion5 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a phase II, open-label, randomized trial assessing citicoline's effect on cognitive decline after delirium in older adults with hip fractures. Patients with delirium are enrolled after screening for inclusion-exclusion criteria, and then randomized 1:1 to receive citicoline or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Bellelli, Medical doctor, full professor, Principal investigator, University of Milano-Bicocca, IRCCS San Gerardo dei Tintori Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804498
- Sponsor's protocol ID
- 2025-522306-21-00
- Other IDs
- 2025
- Acronym
- CITADEL
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pseudonymized IPD may be shared with other researchers under reasonable written request to the Principal Investigator of this study.
Publications
Krogseth M, Davis D, Jackson TA, Zetterberg H, Watne LO, Lindberg M, Chitalu P, Tsui A, Selbaek G, Wyller TB. Delirium, neurofilament light chain, and progressive cognitive impairment: analysis of a prospective Norwegian population-based cohort. Lancet Healthy Longev. 2023 Aug;4(8):e399-e408. doi: 10.1016/S2666-7568(23)00098-3. Epub 2023 Jul 14.
PubMed 37459878Richardson SJ, Davis DHJ, Stephan BCM, Robinson L, Brayne C, Barnes LE, Taylor JP, Parker SG, Allan LM. Recurrent delirium over 12 months predicts dementia: results of the Delirium and Cognitive Impact in Dementia (DECIDE) study. Age Ageing. 2021 May 5;50(3):914-920. doi: 10.1093/ageing/afaa244.
PubMed 33320945Alvarez XA, Mouzo R, Pichel V, Perez P, Laredo M, Fernandez-Novoa L, Corzo L, Zas R, Alcaraz M, Secades JJ, Lozano R, Cacabelos R. Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. Methods Find Exp Clin Pharmacol. 1999 Nov;21(9):633-44.
PubMed 10669911Caamano J, Gomez MJ, Franco A, Cacabelos R. Effects of CDP-choline on cognition and cerebral hemodynamics in patients with Alzheimer's disease. Methods Find Exp Clin Pharmacol. 1994 Apr;16(3):211-8.
PubMed 7913981Franco-Maside A, Caamano J, Gomez MJ, Cacabelos R. Brain mapping activity and mental performance after chronic treatment with CDP-choline in Alzheimer's disease. Methods Find Exp Clin Pharmacol. 1994 Oct;16(8):597-607.
PubMed 7760585Zhao X, Huo X, Meng Y, Zhao R, Liu X, Chen J, Mao Z, Li M. The efficacy of different doses of citicoline in improving the prognosis of patients with acute ischemic stroke based on network meta-analysis. Front Pharmacol. 2025 Apr 4;16:1529647. doi: 10.3389/fphar.2025.1529647. eCollection 2025.
PubMed 40255575Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982 Sep;139(9):1136-9. doi: 10.1176/ajp.139.9.1136.
PubMed 7114305Galvin JE, Roe CM, Powlishta KK, Coats MA, Muich SJ, Grant E, Miller JP, Storandt M, Morris JC. The AD8: a brief informant interview to detect dementia. Neurology. 2005 Aug 23;65(4):559-64. doi: 10.1212/01.wnl.0000172958.95282.2a.
PubMed 16116116Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.
PubMed 24590568Welch SA, Ward RE, Beauchamp MK, Leveille SG, Travison T, Bean JF. The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients. J Am Med Dir Assoc. 2021 Aug;22(8):1646-1651. doi: 10.1016/j.jamda.2020.09.038. Epub 2020 Nov 13.
PubMed 33191134Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Secades JJ, Gareri P. Citicoline: pharmacological and clinical review, 2022 update. Rev Neurol. 2022 Nov 30;75(s05):S1-S89. doi: 10.33588/rn.75s05.2022311. English, Spanish.
PubMed 36544369Grieb P. Neuroprotective properties of citicoline: facts, doubts and unresolved issues. CNS Drugs. 2014 Mar;28(3):185-93. doi: 10.1007/s40263-014-0144-8.
PubMed 24504829Gutierrez-Fernandez M, Rodriguez-Frutos B, Fuentes B, Vallejo-Cremades MT, Alvarez-Grech J, Exposito-Alcaide M, Diez-Tejedor E. CDP-choline treatment induces brain plasticity markers expression in experimental animal stroke. Neurochem Int. 2012 Feb;60(3):310-7. doi: 10.1016/j.neuint.2011.12.015. Epub 2011 Dec 30.
PubMed 22226841Liu X, Yu Y, Zhu S. Inflammatory markers in postoperative delirium (POD) and cognitive dysfunction (POCD): A meta-analysis of observational studies. PLoS One. 2018 Apr 11;13(4):e0195659. doi: 10.1371/journal.pone.0195659. eCollection 2018.
PubMed 29641605
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of CITicoline (TRAUSAN) in Preventing Cognitive Decline After DELirium in Older Adults With Proximal Hip Fracture - The CITADEL Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07804498
- Acronym / sponsor ID
- CITADEL / 2025-522306-21-00
- Conditions
- Cognitive Decline, Delirium
- Keywords
- Cognitive decline, Delirium, Citicoline, Hip fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 5 Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a phase II, open-label, randomized trial assessing citicoline's effect on cognitive decline after delirium in older adults with hip fractures. Patients with delirium are enrolled after screening for inclusion-exclusion criteria, and then randomized 1:1 to receive citicoline or usual care.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Citicoline Intervention Group | Experimental | Drug: CiticolineParticipants 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. |
| No Intervention: Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
- Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
Key exclusion criteria (5 listed)
- 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
- Persistent in-hospital delirium (≥ 6 days or still present 24 hours prior to discharge).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineCiticoline 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. | Drug | Experimental: Citicoline Intervention Group |
Primary outcome
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
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) performed at discharge and at 6 months post-randomization
3 secondary outcomes
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.
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.
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.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 37459878Krogseth M, Davis D, Jackson TA, Zetterberg H, Watne LO, Lindberg M, Chitalu P, Tsui A, Selbaek G, Wyller TB. Delirium, neurofilament light chain, and progressive cognitive impairment: analysis of a prospective Norwegian population-based cohort. Lancet Healthy Longev. 2023 Aug;4(8):e399-e408. doi: 10.1016/S2666-7568(23)00098-3. Epub 2023 Jul 14.
- Background: PubMed 33320945Richardson SJ, Davis DHJ, Stephan BCM, Robinson L, Brayne C, Barnes LE, Taylor JP, Parker SG, Allan LM. Recurrent delirium over 12 months predicts dementia: results of the Delirium and Cognitive Impact in Dementia (DECIDE) study. Age Ageing. 2021 May 5;50(3):914-920. doi: 10.1093/ageing/afaa244.
- Background: PubMed 10669911Alvarez XA, Mouzo R, Pichel V, Perez P, Laredo M, Fernandez-Novoa L, Corzo L, Zas R, Alcaraz M, Secades JJ, Lozano R, Cacabelos R. Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. Methods Find Exp Clin Pharmacol. 1999 Nov;21(9):633-44.
- Background: PubMed 7913981Caamano J, Gomez MJ, Franco A, Cacabelos R. Effects of CDP-choline on cognition and cerebral hemodynamics in patients with Alzheimer's disease. Methods Find Exp Clin Pharmacol. 1994 Apr;16(3):211-8.
- Background: PubMed 7760585Franco-Maside A, Caamano J, Gomez MJ, Cacabelos R. Brain mapping activity and mental performance after chronic treatment with CDP-choline in Alzheimer's disease. Methods Find Exp Clin Pharmacol. 1994 Oct;16(8):597-607.
- Background: PubMed 40255575Zhao X, Huo X, Meng Y, Zhao R, Liu X, Chen J, Mao Z, Li M. The efficacy of different doses of citicoline in improving the prognosis of patients with acute ischemic stroke based on network meta-analysis. Front Pharmacol. 2025 Apr 4;16:1529647. doi: 10.3389/fphar.2025.1529647. eCollection 2025.
- Background: PubMed 7114305Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982 Sep;139(9):1136-9. doi: 10.1176/ajp.139.9.1136.
- Background: PubMed 16116116Galvin JE, Roe CM, Powlishta KK, Coats MA, Muich SJ, Grant E, Miller JP, Storandt M, Morris JC. The AD8: a brief informant interview to detect dementia. Neurology. 2005 Aug 23;65(4):559-64. doi: 10.1212/01.wnl.0000172958.95282.2a.
- Background: PubMed 24590568Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2.
- Background: PubMed 33191134Welch SA, Ward RE, Beauchamp MK, Leveille SG, Travison T, Bean JF. The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients. J Am Med Dir Assoc. 2021 Aug;22(8):1646-1651. doi: 10.1016/j.jamda.2020.09.038. Epub 2020 Nov 13.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 36544369Secades JJ, Gareri P. Citicoline: pharmacological and clinical review, 2022 update. Rev Neurol. 2022 Nov 30;75(s05):S1-S89. doi: 10.33588/rn.75s05.2022311. English, Spanish.
- Individual participant dataSharing planned: Undecided. Pseudonymized IPD may be shared with other researchers under reasonable written request to the Principal Investigator of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Bellelli, Medical doctor, full professor principal investigator
University of Milano-Bicocca, IRCCS San Gerardo dei Tintori Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citicoline in people with Cognitive Decline and Delirium, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Ferrara, Medical doctor and PhD (+39 0392339719, mariacristina.ferrara@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07804498, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.