Cohort Study of Risk Factors for Postoperative Cognitive Decline

Cognitive Decline Clinical Trial

— POCD  

Official title:

Cohort Study of Risk Factors for Postoperative Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676738
• Other study ID #: 17595
• Status: Completed
• Start date: March 26, 2018
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Presently, the role of either genetic factors or biological sex in the development of postoperative cognitive dysfunction (POCD) is unknown. There is a critical need to determine which individuals are at high-risk for developing POCD by virtue of biological sex or genetic predisposition. The knowledge gained in the described research has the potential to shed light on mechanistic pathways, a necessary next step in order to ultimately identify therapeutic strategies.

Description:

Adults 65 years and older represent the fastest-growing age group in the United States, and account for one third of all surgical patients. These older adults are at the highest risk for deleterious postoperative neurocognitive outcomes. Postoperative cognitive dysfunction (POCD) occurs in up to 40% of older adults after major non-cardiac surgery. POCD is a syndrome characterized by a decrease in performance on neuropsychological test battery from before to after surgery. Neuropsychological testing for POCD typically spans cognitive domains including memory, attention, concentration, and/or executive function. There is an increasing body of literature suggesting that exposure to surgery and anesthesia increases the risk of Alzheimer's disease (AD). Surgery and anesthesia enhance neuropathologic changes known to underlie AD including amyloid beta accumulation and aggregation, neuroinflammation, increased levels of tau and tau phosphorylation, and memory decline. However, not everyone with a history of surgery and anesthesia develops POCD, suggesting biological risk factors are involved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• Scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia

• Presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder

• Subjects must have sufficient vision and hearing to complete neuropsychological testing

• Proficient in spoken and written English language

Exclusion Criteria:

• Diagnosed dementia or dementia-related treatment (i.e. donepezil prescription, or memory-care facility residence)

• Significant disease of the central nervous system (CNS) (i.e. Parkinson's disease)

• History of stroke or traumatic brain injury

• Major psychiatric disorder (i.e. schizophrenia)

• Alcohol or drug abuse according to DSM-V within the last 2 years

• Need for urgent/emergent surgery

• Surgery/anesthesia within prior 12 months

• Refusal of consent

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Variables	To determine whether specific genetic variables (i.e. APOE4 or PLA2 alleles) and/or biological sex confer a higher risk to developing postoperative cognitive and functional status decline in older adults.	Six months