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Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care (MADCO-PC)

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ClinicalTrials.gov Identifier: NCT01993836
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimers Disease Postoperative Delirium Post Operative Cognitive Dysfunction Drug: Total intravenous anesthesia with propofol Drug: General anesthesia with isoflurane Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Actual Study Start Date : November 2013
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Total Intravenous Anesthesia with Propofol
Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
 Drug: Total intravenous anesthesia with propofol
Active Comparator: General anesthesia with Isoflurane
Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
 Drug: General anesthesia with isoflurane


Outcome Measures
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Primary Outcome Measures :
  1. Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change [ Time Frame: Baseline to 6 weeks ]
    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.

  2. Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change [ Time Frame: Baseline to 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups [ Time Frame: Baseline to 6 weeks ]
    To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 10 cognitive test scores from baseline. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. A negative change score indicating decline and a positive score indicating improvement. The resulting outcome measure is unbounded with a standard deviation of 0.31 in the full surgical cohort.

  2. Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group [ Time Frame: Baseline to 6 weeks ]
    CSF Markers of Alzheimer's Disease over time in the subjects treated with propofol versus those treated with isoflurane.

  3. Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group [ Time Frame: baseline to 6-weeks ]
    Change in ratio of CSF Markers of Alzheimer's Disease over time in the subjects treated with propofol versus those treated with isoflurane.

  4. Perioperative CSF Tau/Abeta Ratio Change [ Time Frame: Baseline to 24 hours ]
    The perioperative change in the CSF tau/Abeta ratio from the start of anesthesia/surgery to 24 hours later.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT01993836


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Miles Berger, MD, PhD Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol and Statistical Analysis Plan  [PDF] December 16, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01993836    
Other Study ID Numbers: Pro00045180
First Posted: November 25, 2013    Key Record Dates
Results First Posted: May 5, 2020
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Duke University:
isoflurane
propofol
total intravenous anesthesia
inhaled anesthetic
volatile anesthetic
 anesthesia
delirium
Post Operative Cognitive Dysfunction
Alzheimer's Disease
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Delirium
Postoperative Cognitive Complications
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
 Neurologic Manifestations
Cognition Disorders
Postoperative Complications
Pathologic Processes
Anesthetics
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation