Cohort Study of Risk Factors for Postoperative Cognitive Decline

NCT03676738 | Completed

• 1 other identifier: 17595
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Decline

Keywords

Anesthesia, Risk Factors, Age

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

In-patient spine surgery

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

Non-surgical spine care

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

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who present to spine clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained for DNA extraction and storage. Genotyping will be done in batches.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Katie Schenning

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: March 26, 2018
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)