CITADEL: Effectiveness of CITicoline in Preventing Cognitive Decline After DELirium

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.

Timeline

Start

2026-06-03

Primary completion

2027-12-05

Completion

2027-12-05

Publications

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• Background Morandi A, Di Santo SG, Zambon A, Mazzone A, Cherubini A, Mossello E, Bo M, Marengoni A, Bianchetti A, Cappa S, Fimognari F, Antonelli Incalzi R, Gareri P, Perticone F, Campanini M, Penco I, Montorsi M, Di Bari M, Trabucchi M, Bellelli G; Italian Study Group on Delirium (ISGoD). Delirium, Dementia, and In-Hospital Mortality: The Results From the Italian Delirium Day 2016, A National Multicenter Study. J Gerontol A Biol Sci Med Sci. 2019 May 16;74(6):910-916. doi: 10.1093/gerona/gly154.
• Background Bellelli G, Morandi A, Di Santo SG, Mazzone A, Cherubini A, Mossello E, Bo M, Bianchetti A, Rozzini R, Zanetti E, Musicco M, Ferrari A, Ferrara N, Trabucchi M; Italian Study Group on Delirium (ISGoD). "Delirium Day": a nationwide point prevalence study of delirium in older hospitalized patients using an easy standardized diagnostic tool. BMC Med. 2016 Jul 18;14:106. doi: 10.1186/s12916-016-0649-8.
• Background Gibb K, Seeley A, Quinn T, Siddiqi N, Shenkin S, Rockwood K, Davis D. The consistent burden in published estimates of delirium occurrence in medical inpatients over four decades: a systematic review and meta-analysis study. Age Ageing. 2020 Apr 27;49(3):352-360. doi: 10.1093/ageing/afaa040.

Drugs

Indications