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

This study is currently recruiting participants.
Verified November 2016 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993836
First Posted: November 25, 2013
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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 Intervention Phase
Alzheimers Disease Postoperative Delirium Post Operative Cognitive Dysfunction Drug: Total intravenous anesthesia with propofol Drug: General anesthesia with isoflurane Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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:
  • 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.


  • 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.

  • 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.


Estimated Enrollment: 140
Study Start Date: November 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Miles Berger, MD, PhD miles.berger@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Miles Berger, MD, PhD       miles.berger@duke.edu   
Contact: Alicia Pucci, BSN, RN       alicia.pucci@duke.edu   
Principal Investigator: Miles Berger, MD, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Miles Berger, MD, PhD Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01993836     History of Changes
Other Study ID Numbers: Pro00045180
First Submitted: November 15, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2016
Last Verified: November 2016

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:
Anesthetics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation
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
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives