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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
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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

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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


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



Primary Outcome Measures :
  1. Assess the correlation between perioperative change in CSF Markers of Alzheimers Disease and perioperative cognitive change. [ Time Frame: up to 6 weeks ]
    We will assess the magnitude of the pearson correlation coefficient for the relationship between perioperative change in CSF Markers of Alzheimers Disease and the perioperative change in the continuous cognitive index score.


Secondary Outcome Measures :
  1. Continuous cognitive index score change [ Time Frame: 6 weeks ]

    We will examine the difference in the continuous cognitive index score over time in the subjects treated with propofol versus those treated with isoflurane.

    Assess the correlation between perioperative change in CSF Markers of Alzheimers Disease and perioperative cognitive change.


  2. Assess CSF Markers of Alzheimers Disease [ Time Frame: up to 6 weeks ]
    We will examine CSF Markers of Alzheimer's Disease over time in the subjects treated with propofol versus those treated with isoflurane.

  3. Perioperative CSF Tau/Abeta ratio change [ Time Frame: 24 hours ]
    We will measure the perioperative change in the CSF tau/Abeta ratio from the start of anesthesia/surgery to 24 hours later.



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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.

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

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01993836     History of Changes
Other Study ID Numbers: Pro00045180
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: May 2019

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
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Anesthetics
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation