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Completed

NCT Number: NCT05991830

Inflammatory Markers and Level of Cortical Hyperactivity

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (>65 years). Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease. In this project we will seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6 and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile, Santiago, RM, Chile

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About this study

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (>65 years). It is now known that markers of damage begin decades before symptoms can be detected, at the stage called preclinical early AD, which progresses inexorably to mild cognitive impairment and ends in severe Alzheimer's dementia. Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease, however, they have not been directly related in a clinical context. In this project we will seek to relate the levels of the proinflammatory cytokines IL-1beta, IL-6 and TNF-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery. The main goal of this project is to determine the levels of inflammatory markers and cortical hyperactivity in older adults. Methodology: the project is an exploratory observational study of a prospective cohort of patients > 60 years of age who will undergo elective surgery under general anesthesia. In the preoperative period, peripheral venous blood samples will be obtained and stored at -80 ° C and then analyzed by the SIMOA® analyzer, fully automated and digital equipment for performing immunoassays, based on SIMOA® technology, which provide an ultrasensitive signal and / or measurement up to 1000 times greater than conventional immunoassays (in the femtomolar range) of proteins. On the other hand, EEG signal at 128 Hz and other variables from BIS® monitor will be recorded to determine the level of cortical hyperactivity.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults over 60 years of age undergoing elective surgery
  • Able to understand and sign an informed consent form

Exclusion criteria

  • Diagnosis of other neurological pathologies
  • No active acute or chronic decompensated diseases
  • No severe psychiatric illnesses
  • Propofol allergy

Treatment and study plan

General Anesthesia

Procedure

Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken

Primary outcomes

  1. MoCA score

    Time frame: Baseline (Day 0)

    Score (0 to 30)

Secondary outcomes

  1. Intraoperative EEG

    Time frame: Intraoperative (Day 0)

    EEG parameters

  2. Aβ40

    Time frame: Baseline (Day 0)

    Aβ40 plasma concentration

  3. Aβ42

    Time frame: Baseline (Day 0)

    Aβ42 plasma concentration

  4. GFAP™

    Time frame: Baseline (Day 0)

    Glial Fibrillary Acidic Protein (GFAP™) plasma concentration

  5. Nf-L

    Time frame: Baseline (Day 0)

    Neurofilament light (Nf-L) plasma concentration

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery

Acronym: IMCH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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