Inflammatory Markers and Level of Cortical Hyperactivity

Cognition Disorder Clinical Trial

— IMCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991830
• Other study ID #: OAIC: 1311/22
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: University of Chile
• Contact: Antonello Penna, MD, PhD
• Phone: +56956766623
• Email: apenna[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults over 60 years of age undergoing elective surgery

2. Able to understand and sign an informed consent form

Exclusion Criteria:

1. Diagnosis of other neurological pathologies

2. No active acute or chronic decompensated diseases

3. No severe psychiatric illnesses

4. Propofol allergy

Related Conditions & MeSH terms

• Cognition Disorder
• Cognition Disorders

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MoCA score	Score (0 to 30)	Baseline (Day 0)
Secondary	Intraoperative EEG	EEG parameters	Intraoperative (Day 0)
Secondary	Aß40	Aß40 plasma concentration	Baseline (Day 0)
Secondary	Aß42	Aß42 plasma concentration	Baseline (Day 0)
Secondary	GFAP™	Glial Fibrillary Acidic Protein (GFAP™) plasma concentration	Baseline (Day 0)
Secondary	Nf-L	Neurofilament light (Nf-L) plasma concentration	Baseline (Day 0)