Inflammatory Markers and Level of Cortical Hyperactivity

NCT05991830 | Completed

• 1 other identifier: OAIC: 1311/22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cognition Disorder

Outcome Measures

Primary Outcomes (1)

• MoCA score

  Score (0 to 30)

  Baseline (Day 0)

Secondary Outcomes (5)

• Intraoperative EEG

  Intraoperative (Day 0)

• Aβ40

  Baseline (Day 0)

• Aβ42

  Baseline (Day 0)

• GFAP™

  Baseline (Day 0)

• Nf-L

  Baseline (Day 0)

Study Arms (1)

Older adults > 60 years

Procedure: General anesthesia

Interventions

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

Older adults > 60 years

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients \> 60 years of age who will undergo elective surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

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

Santiago, RM, 7690306, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Cognition Disorders

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Pedro Lobos, PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Antonello Penna, MD, PhD

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CL (2)