Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

Postoperative Delirium Clinical Trial

— MADCO-PC  

Official title:

Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993836
• Other study ID #: Pro00045180
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: January 10, 2019

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease
• Cognitive Dysfunction
• Delirium
• Post Operative Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Delirium

Intervention

Drug:
• Total intravenous anesthesia with propofol

• General anesthesia with isoflurane

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change	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.	Baseline to 6 weeks
Primary	Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change	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.	Baseline to 6 weeks
Secondary	Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups	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.	Baseline to 6 weeks
Secondary	Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group	CSF Markers of Alzheimer's Disease over time in the subjects treated with propofol versus those treated with isoflurane.	Baseline to 6 weeks
Secondary	Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group	Change in ratio of CSF Markers of Alzheimer's Disease over time in the subjects treated with propofol versus those treated with isoflurane.	baseline to 6-weeks
Secondary	Perioperative CSF Tau/Abeta Ratio Change	The perioperative change in the CSF tau/Abeta ratio from the start of anesthesia/surgery to 24 hours later.	Baseline to 24 hours