Cognition DisorderIMCHNCT05991830
Inflammatory Markers and Level of Cortical Hyperactivity
An observational study of Cognition Disorder, run by University of Chile at 2 sites in Chile.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cognition Disorder
- What is being tested?
- General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesChile
- Study dates
- 1 Aug 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Cohort of patients > 60 years of age who will undergo elective surgery under general anesthesia
Who may be able to join
- Adults over 60 years of age undergoing elective surgery
- Able to understand and sign an informed consent form
Who cannot join
- Diagnosis of other neurological pathologies
- No active acute or chronic decompensated diseases
- No severe psychiatric illnesses
- Propofol allergy
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
About this study
Official title: Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery
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.
Read the 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.
- Conditions
- Cognition Disorder
- Being tested
- General anesthesia
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken
| Study group | Role | What they receive |
|---|---|---|
| Older adults > 60 years | Not described Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA score
Score (0 to 30)
Measured: Baseline (Day 0)
Secondary outcomes (5)
Intraoperative EEG
EEG parameters
Measured: Intraoperative (Day 0)
Aβ40
Aβ40 plasma concentration
Measured: Baseline (Day 0)
Aβ42
Aβ42 plasma concentration
Measured: Baseline (Day 0)
GFAP™
Glial Fibrillary Acidic Protein (GFAP™) plasma concentration
Measured: Baseline (Day 0)
Nf-L
Neurofilament light (Nf-L) plasma concentration
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Lobos, PhD, Principal investigator, University of ChileAntonello Penna, MD, PhD, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991830
- Sponsor's protocol ID
- OAIC: 1311/22
- Acronym
- IMCH
- Status last verified
- Oct 2025
- First submitted
- 7 Aug 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared based on individual requests made directly to study investigators
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT05991830
- Acronym / sponsor ID
- IMCH / OAIC: 1311/22
- Conditions
- Cognition Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults > 60 years | – | Procedure: General anesthesia |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients > 60 years of age who will undergo elective surgery under general anesthesia
Key inclusion criteria (2 listed)
- Adults over 60 years of age undergoing elective surgery
- Able to understand and sign an informed consent form
Key exclusion criteria (4 listed)
- Diagnosis of other neurological pathologies
- No active acute or chronic decompensated diseases
- No severe psychiatric illnesses
- Propofol allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaOlder adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken | Procedure or surgery | Older adults > 60 years |
Primary outcome
MoCA score
Time frame: Baseline (Day 0)
Score (0 to 30)
5 secondary outcomes
Intraoperative EEG
Time frame: Intraoperative (Day 0)
Aβ40
Time frame: Baseline (Day 0)
Aβ42
Time frame: Baseline (Day 0)
GFAP™
Time frame: Baseline (Day 0)
Nf-L
Time frame: Baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Undecided. Data will be shared based on individual requests made directly to study investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Lobos, PhD principal investigator
University of Chile
Antonello Penna, MD, PhD study chair
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorder, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA score (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.