Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care (MADCO-PC)
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|ClinicalTrials.gov Identifier: NCT01993836|
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : January 19, 2018
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
U.S. FDA Resources
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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993836
|Contact: Miles Berger, MD, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Miles Berger, MD, PhD email@example.com|
|Contact: Alicia Pucci, BSN, RN firstname.lastname@example.org|
|Principal Investigator: Miles Berger, MD, PhD|
|Principal Investigator:||Miles Berger, MD, PhD||Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division|