Cognitive DysfunctionNCT05419596
The Analysis of Gene Variants Related to POCD in Elderly Patients
An observational study of Cognitive Dysfunction, run by Istanbul University.
Trial summary
The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High… Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Urologic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 25 Jul 2023
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are over 60 years old and scheduled for elective/semielective major urologic surgery
Who may be able to join
- Patients over age of 60 years
- Patients scheduled for major urologic surgery
Who cannot join
- Failure of the patient or the person with legal authority to make a decision about him/her.
- Patients with severe hearing-vision problems before surgery.
- Patients with severe neurological-psychiatric disorders before surgery.
- Patients who cannot find a common language.
- Emergency surgeries
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Analysis of Gene Variants Related to POCD in Elderly Patients: a Prospective, Observational Study
The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High affinity choline uptake activity, and Acetil Choline (Ach) activity are decreased in Alzheimer disease.We know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing.
Cholinergic neuron located basal section of forebrain degenerate extensively in Alzheimer disease which shares similarities with postoperative delirium and POCD. Ach binds to two well-known receptors in brain that are Nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and Muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and POCD. Dysfunction of cholinergic system may be one key aspect of postoperative DELIRIUM, POCD and ALZHEIMER disease.
In this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in Alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. Therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (Preoperative and postoperative blood samples for each patient) which are APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6, TREM.
- Conditions
- Cognitive Dysfunction
- Being tested
- Urologic Surgery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urologic SurgeryProcedure or surgery
Patients undergoing major urologic surgery will be examined with blood samples that will be taken preoperatively and postoperatively. Accordingly several gene variants and proteins will be examined for patients with or without postoperative cognitive dysfunction. These proteins consist of APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 - complement receptor 1 , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2).
| Study group | Role | What they receive |
|---|---|---|
| Major Urologic Surgery Group | Elder patients who undergo major urologic surgery will be investigated for the change in genomic protein that are related to cognition. These proteins are APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2) Receives: Procedure: Urologic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-6 levels in elder atients undergoing major urologic surgery
Major urologic surgery patients will be evaluated for their different genomic protein levels that are possibly related to cognitive disorders. These proteins consist of APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, Interleukin- 6, Triggering receptor expressed on myeloid cells2 (TREM2). Accordingly two blood samples will be gathered from each patient in the preoperative and postoperative period.
Measured: From preoperative 1 hour to postoperative 2 hours
Secondary outcomes (8)
Addenbrooke cognitive examinations change (Preoperative to postoperative)
Addenbrooke test will be applied the day before the surgery (T1) and 7 days after the surgery (T2). 0 reflecting the worst and 100 reflecting the best values, 1 standart deviation worsening between the tests will be accepted as Postoperative Cognitive Dysfunction (POCD). Patients with POCD will be accepted as Group POCD (+), without POCD will be accepted as Group POCD (-)
Measured: Up to Postoperative 7 days.
Addenbrooke cognitive examinations change for the chronic period
Third Addenbrooke test will be applied on the postoperative third month (T3). Difference between T3 and T2 will be recorded
Measured: Up to postoperative three months
The difference in IL-6 between the groups
Postoperative IL-6 level difference in Group POCD (+) versus Group POCD (-).
Measured: Up to postoperative 1 hour
DNA sequence analysis of APOE gene
DNA sequence analysis of APOE in whole patient group.
Measured: Up to postoperative 1 hour
DNA sequence analaysis of phospatydil-inositol binding clathrin gene
DNA sequence analaysis of phospatydil-inositol binding clathrin gene in whole patient group
Measured: Up to postoperative 1 hour
DNA sequence analysis of complement receptor 1 protein gene
DNA sequence analaysis of complement receptor 1 protein gene in whole patient group
Measured: Up to postoperative 1 hour
DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2)
DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2) in whole patient group
Measured: Up to postoperative 1 hour
DNA sequence analysis of ATP-binding cassette transporter gene
DNA sequence analysis of ATP-binding cassette transporter gene in whole patient group
Measured: Up to postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion25 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419596
- Sponsor's protocol ID
- 2022/711
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Gene Variants Related to POCD in Elderly Patients: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05419596
- Acronym / sponsor ID
- 2022/711
- Conditions
- Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 25 Jul 2023 (estimated)
- First posted
- 15 Jun 2022 (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.
The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High affinity choline uptake activity, and Acetil Choline (Ach) activity are decreased in Alzheimer disease.We know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing.
Cholinergic neuron located basal section of forebrain degenerate extensively in Alzheimer disease which shares similarities with postoperative delirium and POCD. Ach binds to two well-known receptors in brain that are Nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and Muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and POCD. Dysfunction of cholinergic system may be one key aspect of postoperative DELIRIUM, POCD and ALZHEIMER disease.
In this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in Alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. Therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (Preoperative and postoperative blood samples for each patient) which are APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6, TREM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Urologic Surgery Group | – | Procedure: Urologic SurgeryElder patients who undergo major urologic surgery will be investigated for the change in genomic protein that are related to cognition. These proteins are APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are over 60 years old and scheduled for elective/semielective major urologic surgery
Key inclusion criteria (2 listed)
- Patients over age of 60 years
- Patients scheduled for major urologic surgery
Key exclusion criteria (5 listed)
- Failure of the patient or the person with legal authority to make a decision about him/her.
- Patients with severe hearing-vision problems before surgery.
- Patients with severe neurological-psychiatric disorders before surgery.
- Patients who cannot find a common language.
- Emergency surgeries
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 |
|---|---|---|
| Urologic SurgeryPatients undergoing major urologic surgery will be examined with blood samples that will be taken preoperatively and postoperatively. Accordingly several gene variants and proteins will be examined for patients with or without postoperative cognitive dysfunction. These proteins consist of APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 - complement receptor 1 , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2). | Procedure or surgery | Major Urologic Surgery Group |
Primary outcome
Change in Interleukin-6 levels in elder atients undergoing major urologic surgery
Time frame: From preoperative 1 hour to postoperative 2 hours
Major urologic surgery patients will be evaluated for their different genomic protein levels that are possibly related to cognitive disorders. These proteins consist of APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, Interleukin- 6, Triggering receptor expressed on myeloid cells2 (TREM2). Accordingly two blood samples will be gathered from each patient in the preoperative and postoperative period.
8 secondary outcomes
Addenbrooke cognitive examinations change (Preoperative to postoperative)
Time frame: Up to Postoperative 7 days.
Addenbrooke cognitive examinations change for the chronic period
Time frame: Up to postoperative three months
The difference in IL-6 between the groups
Time frame: Up to postoperative 1 hour
DNA sequence analysis of APOE gene
Time frame: Up to postoperative 1 hour
DNA sequence analaysis of phospatydil-inositol binding clathrin gene
Time frame: Up to postoperative 1 hour
DNA sequence analysis of complement receptor 1 protein gene
Time frame: Up to postoperative 1 hour
DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2)
Time frame: Up to postoperative 1 hour
DNA sequence analysis of ATP-binding cassette transporter gene
Time frame: Up to postoperative 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Istanbul University.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meltem Savran Karadeniz, Assoc. Prof. (00904142000 ext. 31742, savran@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin-6 levels in elder atients undergoing major urologic surgery (time frame: From preoperative 1 hour to postoperative 2 hours). 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 15 Jun 2022.