Postoperative Cognitive DysfunctionNCT07681063
Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery
A study testing co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in people with Postoperative Cognitive Dysfunction, run by Fondazione IRCCS San Gerardo dei Tintori at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- 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
- Age ≥ 65 years
- Both genders
- Undergoing elective aortic or mitral valve replacement/reconstruction with or without coronary artery bypass grafting (CABG), at the Cardiac Surgery Unit of IRCCS San Gerardo dei Tintori Foundation (Monza, Italy)
- Prognosis quoad vitam ≥ 3 months
- Availability of a formal or informal caregiver who can assist the participant in taking the prescribed dose and following the visit schedule
- Any concomitant therapy should be stable
- Written informed consent obtained prior to randomization (from the participant or caregiver if the participant is unable to sign but clearly expresses the will to participate)
Who cannot join
- Severe dementia diagnosis
- Preoperative clinical diagnosis of delirium
- Other treatments/medications that may improve cognition
- Current treatment with m/umPEA or PEALut (Glialia®), or its use within 90 days prior to enrollment
- Contraindications to the use of PEALut, including allergy to excipients contained in the supplement and previous adverse reactions to PEALut
- Other clinical conditions or situations that could interfere with the study or prevent optimal participation, as judged by the researchers
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
Fondazione IRCCS San Gerardo dei Tintori
Monza
Clinical Office, ricerca.clinica@irccs-sangerardo.it
About this study
Official title: Palmitoylethanolamide/Luteolin for the Maintenance of Cognitive Performance in Older Adults Undergoing Cardiac Surgery
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.
Read more
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml), Standard of Care
- Keywords
- Neuroinflammation, Palmitoylethanolamide, Luteolin, Postoperative Cognitive Dysfunction, Cardiac Surgery, Cognitive Impairment
- Medical subject headings
- Postoperative Cognitive Complications, Neuroinflammatory Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml)Dietary supplement
Also called Glialia® oral suspension, PEALut® oral suspension
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
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| PEALut® + Standard of Care | Experimental | Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care Receives: Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml); Other: Standard of Care |
| Standard of Care | Active comparator | Participants receive only the Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, hospital discharge (approximately postoperative day 7-10, depending on clinical course), 3 months after treatment, and 3 months after the end of treatment
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months after treatment, and 3 months after the end of treatment
Rehospitalization
Incidence of rehospitalization
Measured: From 24 hours after the intervention to 6 months after randomization
Mortality
Incidence of mortality
Measured: 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.
Measured: 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.
Measured: Baseline
Plasma Aβ42 levels
Plasma levels of Amyloid beta 42 (Aβ42) will be measured in blood samples using standard clinical laboratory assays.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Bellelli, Principal investigator, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681063
- Sponsor's protocol ID
- PEGASUS COG
- Status last verified
- May 2026
- First submitted
- 11 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savageau JA, Stanton BA, Jenkins CD, Frater RW. Neuropsychological dysfunction following elective cardiac operation. II. A six-month reassessment. J Thorac Cardiovasc Surg. 1982 Oct;84(4):595-600.
PubMed 6981735Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362Suraarunsumrit P, Srinonprasert V, Kongmalai T, Suratewat S, Chaikledkaew U, Rattanasiri S, McKay G, Attia J, Thakkinstian A. Outcomes associated with postoperative cognitive dysfunction: a systematic review and meta-analysis. Age Ageing. 2024 Jul 2;53(7):afae160. doi: 10.1093/ageing/afae160.
PubMed 39058915Zhang L, Qiu Y, Zhang ZF, Zhao YF, Ding YM. Current perspectives on postoperative cognitive dysfunction in geriatric patients: insights from clinical practice. Front Med (Lausanne). 2024 Sep 27;11:1466681. doi: 10.3389/fmed.2024.1466681. eCollection 2024.
PubMed 39399113Nobili S, Micheli L, Lucarini E, Toti A, Ghelardini C, Di Cesare Mannelli L. Ultramicronized N-palmitoylethanolamine associated with analgesics: Effects against persistent pain. Pharmacol Ther. 2024 Jun;258:108649. doi: 10.1016/j.pharmthera.2024.108649. Epub 2024 Apr 12.
PubMed 38615798Clayton P, Hill M, Bogoda N, Subah S, Venkatesh R. Palmitoylethanolamide: A Natural Compound for Health Management. Int J Mol Sci. 2021 May 18;22(10):5305. doi: 10.3390/ijms22105305.
PubMed 34069940Colizzi M, Bortoletto R, Colli C, Bonomo E, Pagliaro D, Maso E, Di Gennaro G, Balestrieri M. Therapeutic effect of palmitoylethanolamide in cognitive decline: A systematic review and preliminary meta-analysis of preclinical and clinical evidence. Front Psychiatry. 2022 Oct 28;13:1038122. doi: 10.3389/fpsyt.2022.1038122. eCollection 2022.
PubMed 36387000Caltagirone C, Cisari C, Schievano C, Di Paola R, Cordaro M, Bruschetta G, Esposito E, Cuzzocrea S; Stroke Study Group. Co-ultramicronized Palmitoylethanolamide/Luteolin in the Treatment of Cerebral Ischemia: from Rodent to Man. Transl Stroke Res. 2016 Feb;7(1):54-69. doi: 10.1007/s12975-015-0440-8. Epub 2015 Dec 26.
PubMed 26706245
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmitoylethanolamide/Luteolin for the Maintenance of Cognitive Performance in Older Adults Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07681063
- Acronym / sponsor ID
- PEGASUS COG
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Neuroinflammation, Palmitoylethanolamide, Luteolin, Postoperative Cognitive Dysfunction, Cardiac Surgery, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS San Gerardo dei TintoriUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Jul 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEALut® + Standard of Care | Experimental | Dietary Supplement: co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml), Other: Standard of CareParticipants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care |
| Standard of Care | Active comparator | Other: Standard of CareParticipants receive only the Standard of Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 years
- Both genders
- Undergoing elective aortic or mitral valve replacement/reconstruction with or without coronary artery bypass grafting (CABG), at the Cardiac Surgery Unit of IRCCS San Gerardo dei Tintori Foundation (Monza, Italy)
- Prognosis quoad vitam ≥ 3 months
- Availability of a formal or informal caregiver who can assist the participant in taking the prescribed dose and following the visit schedule
Key exclusion criteria (6 listed)
- Severe dementia diagnosis
- Preoperative clinical diagnosis of delirium
- Other treatments/medications that may improve cognition
- Current treatment with m/umPEA or PEALut (Glialia®), or its use within 90 days prior to enrollment
- Contraindications to the use of PEALut, including allergy to excipients contained in the supplement and previous adverse reactions to PEALut
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 |
|---|---|---|
| co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml)Also: Glialia® oral suspension, PEALut® oral suspensionOral 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 | Dietary supplement | PEALut® + Standard of Care |
| Standard of CareStandard of Care | Other | PEALut® + Standard of Care, Standard of Care |
Primary outcome
Change in 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
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.
19 secondary outcomes
Incidence of Postoperative Cognitive Dysfunction (POCD)
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)
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)
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Instrumental Activities of Daily Living (IADL)
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Short Physical Performance Battery (SPPB)
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Handgrip Strength
Time frame: Baseline, 3 months after treatment, and 3 months after the end of treatment
Rehospitalization
Time frame: From 24 hours after the intervention to 6 months after randomization
Mortality
Time frame: From 24 hours after the intervention to 6 months after randomization
Incidence of Treatment-Related Adverse Events
Time frame: From first treatment administration up to 3 months after the end of treatment
Plasma p-tau217 levels
Time frame: Baseline
Plasma Aβ42 levels
Time frame: Baseline
Change in plasma IL-6 levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma s-RAGE levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GDF-15 levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GFAP levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NSE levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NfL levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma FGF-1 levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma BDNF levels
Time frame: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
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 2 Jul 2026.
- Background: PubMed 6981735Savageau JA, Stanton BA, Jenkins CD, Frater RW. Neuropsychological dysfunction following elective cardiac operation. II. A six-month reassessment. J Thorac Cardiovasc Surg. 1982 Oct;84(4):595-600.
- Background: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
- Background: PubMed 39058915Suraarunsumrit P, Srinonprasert V, Kongmalai T, Suratewat S, Chaikledkaew U, Rattanasiri S, McKay G, Attia J, Thakkinstian A. Outcomes associated with postoperative cognitive dysfunction: a systematic review and meta-analysis. Age Ageing. 2024 Jul 2;53(7):afae160. doi: 10.1093/ageing/afae160.
- Background: PubMed 39399113Zhang L, Qiu Y, Zhang ZF, Zhao YF, Ding YM. Current perspectives on postoperative cognitive dysfunction in geriatric patients: insights from clinical practice. Front Med (Lausanne). 2024 Sep 27;11:1466681. doi: 10.3389/fmed.2024.1466681. eCollection 2024.
- Background: PubMed 38615798Nobili S, Micheli L, Lucarini E, Toti A, Ghelardini C, Di Cesare Mannelli L. Ultramicronized N-palmitoylethanolamine associated with analgesics: Effects against persistent pain. Pharmacol Ther. 2024 Jun;258:108649. doi: 10.1016/j.pharmthera.2024.108649. Epub 2024 Apr 12.
- Background: PubMed 34069940Clayton P, Hill M, Bogoda N, Subah S, Venkatesh R. Palmitoylethanolamide: A Natural Compound for Health Management. Int J Mol Sci. 2021 May 18;22(10):5305. doi: 10.3390/ijms22105305.
- Background: PubMed 36387000Colizzi M, Bortoletto R, Colli C, Bonomo E, Pagliaro D, Maso E, Di Gennaro G, Balestrieri M. Therapeutic effect of palmitoylethanolamide in cognitive decline: A systematic review and preliminary meta-analysis of preclinical and clinical evidence. Front Psychiatry. 2022 Oct 28;13:1038122. doi: 10.3389/fpsyt.2022.1038122. eCollection 2022.
- Background: PubMed 26706245Caltagirone C, Cisari C, Schievano C, Di Paola R, Cordaro M, Bruschetta G, Esposito E, Cuzzocrea S; Stroke Study Group. Co-ultramicronized Palmitoylethanolamide/Luteolin in the Treatment of Cerebral Ischemia: from Rodent to Man. Transl Stroke Res. 2016 Feb;7(1):54-69. doi: 10.1007/s12975-015-0440-8. Epub 2015 Dec 26.
- Individual participant dataSharing planned: No
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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 principal investigator
School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in people with Postoperative Cognitive Dysfunction, run by Fondazione IRCCS San Gerardo dei Tintori 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Jul 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.
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 Giuseppe Bellelli (+39 039 233 3472, giuseppe.bellelli@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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). 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 NCT07681063, which also lists 8 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 2 Jul 2026.