IMCH: Inflammatory Markers and Level of Cortical Hyperactivity

Sponsor

University of Chile (Other)

Overall Status

Recruiting

CT.gov ID

NCT05991830

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognition Disorder	Procedure: General anesthesia

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Older adults > 60 years	Procedure: General anesthesia Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken

Arm

Intervention/Treatment

Older adults > 60 years

Procedure: General anesthesia

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

Outcome Measures

Primary Outcome Measures

MoCA score [Baseline (Day 0)]
Score (0 to 30)

Secondary Outcome Measures

Intraoperative EEG [Intraoperative (Day 0)]
EEG parameters
Aβ40 [Baseline (Day 0)]
Aβ40 plasma concentration
Aβ42 [Baseline (Day 0)]
Aβ42 plasma concentration
GFAP™ [Baseline (Day 0)]
Glial Fibrillary Acidic Protein (GFAP™) plasma concentration
Nf-L [Baseline (Day 0)]
Neurofilament light (Nf-L) plasma concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile	Santiago	RM	Chile	7690306
2	Hospital Clinico de la Universidad de Chile	Santiago	RM	Chile	7690306

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator: Pedro Lobos, PhD, University of Chile
Study Chair: Antonello Penna, MD, PhD, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chile

ClinicalTrials.gov Identifier:

NCT05991830

Other Study ID Numbers:

OAIC: 1311/22

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognition Disorders

Anesthetics

Study Results

No Results Posted as of Aug 15, 2023