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Completed

NCT Number: NCT01993836

Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

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.

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Key information

Conditions

Alzheimers Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Confusion Delirium Dementia Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Cognitive Dysfunction Postoperative Complications Postoperative Delirium Signs and Symptoms Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total intravenous anesthesia with propofol

Drug

General anesthesia with isoflurane

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: MADCO-PC

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2013
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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