Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
MADCO-PC
1 other identifier
interventional
191
1 country
1
Brief Summary
This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedResults Posted
Study results publicly available
May 5, 2020
CompletedMarch 22, 2023
March 1, 2023
5.2 years
November 15, 2013
January 7, 2020
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
Spearman correlation was used here as the CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
Baseline to 6 weeks
Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
Spearman correlation was used here as the ratio of CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
Baseline to 6 weeks
Secondary Outcomes (4)
Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups
Baseline to 6 weeks
Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group
Baseline to 6 weeks
Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group
baseline to 6-weeks
Perioperative CSF Tau/Abeta Ratio Change
Baseline to 24 hours
Study Arms (2)
Total Intravenous Anesthesia with Propofol
ACTIVE COMPARATORPatients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
General anesthesia with Isoflurane
ACTIVE COMPARATORPatients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
Interventions
Eligibility Criteria
You may qualify if:
- Surgical patients 60 years of age or older
- Surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)
- English speaking ability.
- Ability to give informed consent
You may not qualify if:
- Inmate of a correctional facility (i.e. prisoners).
- Pregnancy
- Documented or suspected family or personal history of malignant hyperthermia.
- Patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (2)
Villalobos D, Reese M, Wright MC, Wong M, Syed A, Park J, Hall A, Browndyke JN, Martucci KT, Devinney MJ, Acker L, Moretti EW, Talbot L, Colin B, Ohlendorf B, Waligorska T, Shaw LM, Whitson HE, Cohen HJ, Mathew JP, Berger M. Perioperative changes in neurocognitive and Alzheimer's disease-related cerebrospinal fluid biomarkers in older patients randomised to isoflurane or propofol for anaesthetic maintenance. Br J Anaesth. 2023 Aug;131(2):328-337. doi: 10.1016/j.bja.2023.04.019. Epub 2023 Jun 2.
PMID: 37271721DERIVEDBerger M, Browndyke JN, Cooter Wright M, Nobuhara C, Reese M, Acker L, Bullock WM, Colin BJ, Devinney MJ, Moretti EW, Moul JW, Ohlendorf B, Laskowitz DT, Waligorska T, Shaw LM, Whitson HE, Cohen HJ, Mathew JP; MADCO-PC Investigators. Postoperative changes in cognition and cerebrospinal fluid neurodegenerative disease biomarkers. Ann Clin Transl Neurol. 2022 Feb;9(2):155-170. doi: 10.1002/acn3.51499. Epub 2022 Feb 1.
PMID: 35104057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Miles Berger, MD, PhD
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Miles Berger, MD, PhD
Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2013
First Posted
November 25, 2013
Study Start
November 1, 2013
Primary Completion
January 10, 2019
Study Completion
January 10, 2019
Last Updated
March 22, 2023
Results First Posted
May 5, 2020
Record last verified: 2023-03