Palmitoylethanolamide/Luteolin for the Maintenance of Cognitive Performance in Older Adults Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in cognitive performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in cognitive performance
时间窗: 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.
次要结局
- Incidence of Postoperative Cognitive Dysfunction (POCD)(Hospital discharge (approximately postoperative day 7-10, depending on clinical course), and 3 months after treatment)
- Incidence, subtype and duration of postoperative delirium (POD)(Daily, from 24 hours after the intervention until hospital discharge (approximately postoperative day 7-10, depending on clinical course))
- Mortality(From 24 hours after the intervention to 6 months after randomization)
- Change in Activities of Daily Living (ADL)(Baseline, 3 months after treatment, and 3 months after the end of treatment)
- Change in Instrumental Activities of Daily Living (IADL)(Baseline, 3 months after treatment, and 3 months after the end of treatment)
- Change in Short Physical Performance Battery (SPPB)(Baseline, 3 months after treatment, and 3 months after the end of treatment)
- Change in Handgrip Strength(Baseline, 3 months after treatment, and 3 months after the end of treatment)
- Rehospitalization(From 24 hours after the intervention to 6 months after randomization)
- Incidence of Treatment-Related Adverse Events(From first treatment administration up to 3 months after the end of treatment)
- Plasma p-tau217 levels(Baseline)
- Plasma Aβ42 levels(Baseline)
- Change in plasma IL-6 levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma s-RAGE levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma GDF-15 levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma GFAP levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma NSE levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma NfL levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma FGF-1 levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)
- Change in plasma BDNF levels(Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment)