Phase 4
Completed N=191
Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Alzheimer's Disease · Postoperative Delirium · Post Operative Cognitive Dysfunction
Source: ClinicalTrials.gov NCT01993836 ↗
Enrolled (actual)
191
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change — -1.21; -5.09; -0.44 pg/ml
◆ Published Evidence
Established
38citations · ~10 / year
Postoperative changes in cognition and cerebrospinal fluid neurodegenerative disease biomarkers.
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.
Linked Publications (2)
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Postoperative changes in cognition and cerebrospinal fluid neurodegenerative disease biomarkers.
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Perioperative changes in neurocognitive and Alzheimer's disease-related cerebrospinal fluid biomarkers in older patients randomised to isoflurane or propofol for anaesthetic maintenance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change |
-1.21; -5.09; -0.44 | — |
| PRIMARY Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change |
0.001; 0.002 | — |
| SECONDARY Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups |
0.019; 0.061 | 0.360 |
| SECONDARY Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group |
-0.80; -1.67; -2.10; -9.50; -2.25; 1.10 | 0.532 |
| SECONDARY Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group |
0.00; -0.00; -0.00; 0.01 | 0.439 |
| SECONDARY Perioperative CSF Tau/Abeta Ratio Change |
-0.001 | 0.801 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01993836) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.