Cognitive DeclinePOCDNCT03676738
Cohort Study of Risk Factors for Postoperative Cognitive Decline
An observational study of Cognitive Decline, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Cognitive Decline
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 20 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects who present to spine clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Cognitive Decline
- Keywords
- Anesthesia, Risk Factors, Age
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start26 Mar 2018
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie J. Schenning, Oregon Health and Science University
- Investigators
- Katie Schenning, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676738
- Sponsor's protocol ID
- 17595
- Acronym
- POCD
- Status last verified
- May 2022
- First submitted
- 17 Sep 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Risk Factors for Postoperative Cognitive Decline
- ClinicalTrials.gov ID
- NCT03676738
- Acronym / sponsor ID
- POCD / 17595
- Conditions
- Cognitive Decline
- Keywords
- Anesthesia, Risk Factors, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects who present to spine clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic Variables
Time frame: Six months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Schenning principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Variables (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.