An interventional study of co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) and Standard of Care in Postoperative Cognitive Dysfunction, sponsored by Fondazione IRCCS San Gerardo dei Tintori. Not yet recruiting at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Fondazione IRCCS San Gerardo dei Tintori · Not applicable, Interventional, and Supportive care
Postoperative Cognitive Dysfunction (POCD) is a common complication after surgery, particularly among older adults. It is characterized by cognitive impairment, reduced functional independence, and decreased quality of life. Growing evidence suggests that neuroinflammation plays a relevant role in POCD development and persistence.
Palmitoylethanolamide (PEA) is an endogenous lipid mediator involved in the regulation of neuroinflammatory processes through the modulation of non-neuronal cells, while luteolin is a flavonoid with well-known antioxidant properties. Under conditions of prolonged neuroinflammation, endogenous PEA levels may be insufficient to adequately counteract pro-inflammatory signaling, making exogenous administration necessary.
In this context, exogenous micronized and ultramicronized PEA (mPEA and umPEA) supplementation has been shown to modulate cognitive and executive functions, working memory, language, and activities of daily living. Moreover, the combination of umPEA and luteolin (PEALut) may produce synergistic effects by modulating neuroinflammation and supporting neuronal function.
This study aims to evaluate whether postoperative administration of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 mL), added to standard of care, may contribute to the mitigation of POCD in older adults undergoing elective cardiac surgery, compared to standard care alone.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's planned enrollment of 100 is close to the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Fondazione IRCCS San Gerardo dei Tintori is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care
Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) · Other: Standard of Care
Participants receive only the Standard of Care
Other: Standard of Care
Oral suspension, 10 ml twice daily (every 12 hours), starting within 24 hours post-surgery and for 3 months, in add-on to the Standard of Care
Also known as: Glialia® oral suspension, PEALut® oral suspension
Standard of Care
Change in cognitive performance
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-item screening tool that evaluates multiple cognitive domains, including memory, visuospatial ability, executive function, attention, language, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time frame: Baseline, hospital discharge (approximately postoperative day 7-10, depending on clinical course), 3 months after treatment, and 3 months after the end of treatment
Incidence of Postoperative Cognitive Dysfunction (POCD)
Incidence of POCD will be defined as a decrease of at least 1 standard deviation from baseline MoCA score.
Time frame: Hospital discharge (approximately postoperative day 7-10, depending on clinical course), and 3 months after treatment
Incidence, subtype and duration of postoperative delirium (POD)
Postoperative delirium will be assessed using the 4AT screening tool. A score of ≥4 suggests possible delirium (with or without cognitive impairment), with higher scores indicating greater severity of cognitive disturbance. Positive screenings will be confirmed using DSM-5 criteria. Delirium subtype will be classified using the Delirium Motor Subtyping Scale-4 (DMSS-4), and duration will be recorded in days from onset to resolution.
Time frame: Daily, from 24 hours after the intervention until hospital discharge (approximately postoperative day 7-10, depending on clinical course)
Change in Activities of Daily Living (ADL)
Activities of daily living will be assessed using the six-item Katz Activities of Daily Living (ADL) Index. Scores range from 0 to 6, with higher values indicating greater function.
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Instrumental Activities of Daily Living (IADL)
Functional status will be assessed using the Instrumental Activities of Daily Living (IADL) scale. Scores range from 0 to 8, with higher scores indicating better functional ability.
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Short Physical Performance Battery (SPPB)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and chair stand performance. Scores range from 0 to 12, with higher scores indicating better physical performance.
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Handgrip Strength
Muscle strength will be assessed using a handgrip dynamometer. Handgrip strength will be recorded in kilograms (kg), with higher values indicating greater muscle strength.
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Rehospitalization
Incidence of rehospitalization
Time frame: From 24 hours after the intervention to 6 months after randomization
Mortality
Incidence of mortality
Time frame: From 24 hours after the intervention to 6 months after randomization
Incidence of Treatment-Related Adverse Events
Safety and Adherence assessment will be assessed by monitoring the incidence and severity of adverse events occurring during the study period.
Time frame: From first treatment administration up to 3 months after the end of treatment
Plasma p-tau217 levels
Plasma levels of phosphorylated tau (p-tau217) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline
Plasma Aβ42 levels
Plasma levels of Amyloid beta 42 (Aβ42) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline
Change in plasma IL-6 levels
Plasma levels of Interleukin-6 (IL-6) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma s-RAGE levels
Plasma levels of soluble Receptor for Advanced Glycation End-products (s-RAGE) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GDF-15 levels
Plasma levels of Growth Differentiation Factor-15 (GDF-15) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GFAP levels
Plasma levels of Glial Fibrillary Acidic Protein (GFAP) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NSE levels
Plasma levels of Neuron-Specific Enolase (NSE) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NfL levels
Plasma levels of Neurofilament Light Chain (NfL) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma FGF-1 levels
Plasma levels of Fibroblast Growth Factor-1 (FGF-1) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma BDNF levels
Plasma levels of Brain-Derived Neurotrophic Factor (BDNF) will be measured in blood samples using standard clinical laboratory assays.
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plan to share: No
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Postoperative Cognitive Complications →
Fondazione IRCCS San Gerardo dei Tintori