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Can a daily supplement shield the brain after delirium?

NCT ID NCT07804498

Disease control Sponsor: University of Milano Bicocca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether citicoline, a neuroprotective agent, can prevent or slow cognitive decline in older adults who develop delirium while hospitalized for a hip fracture. Delirium is a common complication that can lead to lasting memory and thinking problems. Participants will be randomly assigned to receive citicoline daily for 6 months after hospital discharge or to receive usual care. Researchers will compare cognitive function at discharge and at 3 and 6 months to see if citicoline makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Citicoline (TRAUSAN), an oral solution taken daily for 6 months
What this could lead to
If it works, citicoline could offer a way to protect memory and thinking in older adults who experience delirium after hip fracture surgery, potentially reducing long-term cognitive decline.
What could go wrong
This is a phase 2 trial with 122 participants, so results may not apply broadly. Citicoline has not been tested for this purpose before, and its benefits remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction delirium hip fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive decline Delirium Hip fracture Perioperative delirium Post-operative cognitive decline in older adults

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS San Gerardo dei Tintori Foundation

    RECRUITING

    Monza, Monza E Brianza, 20900, Italy

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