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The Analysis of Gene Variants Related to POCD in Elderly Patients

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ClinicalTrials.gov Identifier: NCT05419596
Recruitment Status : Not yet recruiting
First Posted : June 15, 2022
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Meltem Savran Karadeniz, Istanbul University

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment
Cognitive Dysfunction Procedure: Urologic Surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Analysis of Gene Variants Related to POCD in Elderly Patients: a Prospective, Observational Study
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 25, 2023

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
 Procedure: Urologic 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Addenbrooke cognitive examinations change (Preoperative to postoperative) [ Time Frame: Up to Postoperative 7 days. ]
    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 (-)

  2. Addenbrooke cognitive examinations change for the chronic period [ Time Frame: Up to postoperative three months ]
    Third Addenbrooke test will be applied on the postoperative third month (T3). Difference between T3 and T2 will be recorded

  3. The difference in IL-6 between the groups [ Time Frame: Up to postoperative 1 hour ]
    Postoperative IL-6 level difference in Group POCD (+) versus Group POCD (-).

  4. DNA sequence analysis of APOE gene [ Time Frame: Up to postoperative 1 hour ]
    DNA sequence analysis of APOE in whole patient group.

  5. DNA sequence analaysis of phospatydil-inositol binding clathrin gene [ Time Frame: Up to postoperative 1 hour ]
    DNA sequence analaysis of phospatydil-inositol binding clathrin gene in whole patient group

  6. DNA sequence analysis of complement receptor 1 protein gene [ Time Frame: Up to postoperative 1 hour ]
    DNA sequence analaysis of complement receptor 1 protein gene in whole patient group

  7. DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2) [ Time Frame: Up to postoperative 1 hour ]
    DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2) in whole patient group

  8. DNA sequence analysis of ATP-binding cassette transporter gene [ Time Frame: Up to postoperative 1 hour ]
    DNA sequence analysis of ATP-binding cassette transporter gene in whole patient group


Biospecimen Retention:   Samples With DNA
Blood samples will be evaluated using DNA sequence analysis, Realtime PCR, and ELISA techniques. Proteins including APOE, phosphatidyl inositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6,Triggering receptor expressed on myeloid cells2 (TREM2) will be investigated.

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are over 60 years old and scheduled for elective/semielective major urologic surgery
Criteria

Inclusion Criteria:

  • Patients over age of 60 years
  • Patients scheduled for major urologic surgery

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05419596


Contacts
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Contact: Meltem Savran Karadeniz, Assoc. Prof. 00904142000 ext 31742 savran@istanbul.edu.tr

Sponsors and Collaborators
Istanbul University
More Information
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Responsible Party: Meltem Savran Karadeniz, Associate Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT05419596    
Other Study ID Numbers: 2022/711
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders