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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05991830
Other study ID # OAIC: 1311/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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)
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