Post-Operative Cognitive Decline in Older AdultsPOCDNCT01786577
Study To Analyze Memory/Thinking Problems In Older Adults After Surgery
An observational study of Post-Operative Cognitive Decline in Older Adults, run by University of Florida at 1 site in United States.
Trial summary
The purpose of the study is to examine specific neuroimaging predictors of memory and executive decline in older adults at various stages after total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Operative Cognitive Decline in Older Adults
- What is being tested?
- Magnetic Resonance Imaging and Cognitive assessment testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2013to 21 Jul 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two age-matched participant groups will be recruited. Healthy non-demented age matched patients undergoing elective total knee arthoplasty, and age, education, and diseased matched (osteoarthritis knee pain;) non-surgery peers.
Who may be able to join
- Planned total unilateral knee antroplasty or non-surgical knee osteoarthritis
- Age 60 years or older at the time of baseline assessment
- Telephone screening and in-person baseline cognitive testing not supportive of dementia
- Handedness: Right handed; restriction to left-right hemisphere laterality and white matter pathways
- Participant and family deny presence of difficulties with Instrumental Activities of Daily Living (IADL)
- All ethnic and racial groups will be recruited
Who cannot join
- Underlying medical diseases likely to limit lifespan or confound outcome analyses:
- cancer requiring treatment in past five years
- serious infectious diseases
- congestive heart failure
- chronic hepatitis
- history of organ transplantation
Show all 24Show fewer
- seizure disorders
- history of head trauma resulting in intensive care
- current diagnosis of alcoholism, drug dependence, history of major tranquilizer use
- Neurodegenerative Exclusions:
- history of major stroke
- exposure to toxins or neuroleptics
- history of encephalitis
- neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear palsy, or significant orthostatic hypertension
- signs of dementia.
- Psychiatric Exclusions:
- major psychiatric disorder
- major depression
- Conditions or behaviors likely to affect imaging or cognitive testing:
- claustrophobia
- non-medical bodily metal, pace-maker device
- less than five years of formal education
- inability to read or write
- self-reported hearing difficulty that interferes with standardized test administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroimaging Biomarkers for Post-Operative Cognitive Decline in Older Adults
The purpose of the study is to examine specific neuroimaging predictors of memory and executive decline in older adults at various stages after total knee replacement surgery.
Read the detailed description
Cognitive impairment after major cardiac or non-cardiac surgery occurs in a high rate for older adults. The results of previous studies indicate that certain neuro-imaging markers can determine which individuals pose a greater risk for memory and thinking changes after surgery. Based on a pilot study, there is evidence that pre-surgical neuroimaging biomarkers associate with memory and executive decline after a well controlled surgical procedure (total knee antroplasty). In this study, researchers will use brain imaging studies to determine which patients are most likely to be affected by cognitive changes after this type of surgery. The use of Magnetic Resonance Imaging (MRI) will help investigators identify brain biomarkers that are associated with cognitive problems, such as white matter abnormalities and changes to small blood vessels. Patients undergoing total knee replacement surgery, as well as a group of non-surgery participants of similar age, education and health status,will receive cognitive testing and MRI brain scans before and after surgery/non-surgery. Researchers will compare and monitor both groups up to one year after surgery/non-surgery.
Prior to enrollment, participants will be asked to review the informed consent and provide written consent to participate in the study. The enrollment phase will involve in-person baseline assessment of cognitive functioning within two weeks of the scheduled surgery/non-surgery in order to rule out exclusion criteria. Testing will be in cooperation with the University of Florida General Clinical Research Center. Post-baseline MRI will be conducted on all participants (surgery/control) within 48 hours of the surgery/pseudo-surgery date to identify acute stroke differences from baseline. Cognitive assessments will be conducted for each participant at three-weeks, three-months, and one-year after surgery.
The research is highly significant because it will be the first study to use in-vivo diffusion imaging methods to examine the contribution of specific presurgical neuroanatomical vulnerabilities on executive and memory cognitive decline after one of the most common orthopedic surgeries sought by older adults. Additionally, it will be the first study to examine how specific neuroimaging biomarkers interact negatively with specific peri-operative variables including emboli number during surgery, embolic changes to the brain, anesthesia depth, and cerebral oxygenation.
The findings of the study will improve pre-surgery screening procedures for older adults and assist with the development of peri-operative interventions that will prevent neurodegenerative disease acceleration.
- Being tested
- Magnetic Resonance Imaging, Cognitive assessment testing
- Keywords
- Neuroimaging Biomarkers, Cognitive Decline in Elderly, Memory, Thinking problems for Older Adults, Executive Decline, Post-operative cognitive change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Also called MRI
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Cognitive assessment testingBehavioural
Also called Cognitive assessement tests
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | 80 patients will undergo total knee replacement surgery; two Magnetic Resonance Imaging scans; cognitive assessment testing. Receives: Other: Magnetic Resonance Imaging; Behavioral: Cognitive assessment testing | |
| Non-Surgery | 80 non-surgery participants will be included as part of the control group; two Magnetic Resonance Imaging scans; cognitive assessment testing. Receives: Other: Magnetic Resonance Imaging; Behavioral: Cognitive assessment testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting Executive Decline
Severity of pre-surgical/baseline neuroimaging markers of cerebrovascular disease will predict post-operative executive decline at 3 weeks, 3 months and 1 year.
Measured: baseline, 3 weeks, 3 months, 1 year
Predicting Memory Decline
Pre-surgical/baseline neuroimaging markers of entorhinal-hippocampal white matter connectivity will predict post-operative memory decline at 3 weeks, 3 months and 1 year.
Measured: baseline, 3 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study start19 Mar 2013
- Primary completion21 Jun 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Operative Cognitive Decline in Older AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Catherine Price, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786577
- Sponsor's protocol ID
- IRB201601040-N
- Other IDs
- R01NR014181-01, 487-2012
- Acronym
- POCD
- Status last verified
- Jul 2019
- First submitted
- 30 Jan 2013
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hizel LP, Warner ED, Wiggins ME, Tanner JJ, Parvataneni H, Davis R, Penney DL, Libon DJ, Tighe P, Garvan CW, Price CC. Clock Drawing Performance Slows for Older Adults After Total Knee Replacement Surgery. Anesth Analg. 2019 Jul;129(1):212-219. doi: 10.1213/ANE.0000000000003735.
PubMed 30273231
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarkers for Post-Operative Cognitive Decline in Older Adults
- ClinicalTrials.gov ID
- NCT01786577
- Acronym / sponsor ID
- POCD / IRB201601040-N
- Keywords
- Neuroimaging Biomarkers, Cognitive Decline in Elderly, Memory, Thinking problems for Older Adults, Executive Decline, Post-operative cognitive change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- 19 Mar 2013 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 8 Feb 2013 (estimated)
- 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.
The purpose of the study is to examine specific neuroimaging predictors of memory and executive decline in older adults at various stages after total knee replacement surgery.
Detailed description
Cognitive impairment after major cardiac or non-cardiac surgery occurs in a high rate for older adults. The results of previous studies indicate that certain neuro-imaging markers can determine which individuals pose a greater risk for memory and thinking changes after surgery. Based on a pilot study, there is evidence that pre-surgical neuroimaging biomarkers associate with memory and executive decline after a well controlled surgical procedure (total knee antroplasty). In this study, researchers will use brain imaging studies to determine which patients are most likely to be affected by cognitive changes after this type of surgery. The use of Magnetic Resonance Imaging (MRI) will help investigators identify brain biomarkers that are associated with cognitive problems, such as white matter abnormalities and changes to small blood vessels. Patients undergoing total knee replacement surgery, as well as a group of non-surgery participants of similar age, education and health status,will receive cognitive testing and MRI brain scans before and after surgery/non-surgery. Researchers will compare and monitor both groups up to one year after surgery/non-surgery.
Prior to enrollment, participants will be asked to review the informed consent and provide written consent to participate in the study. The enrollment phase will involve in-person baseline assessment of cognitive functioning within two weeks of the scheduled surgery/non-surgery in order to rule out exclusion criteria. Testing will be in cooperation with the University of Florida General Clinical Research Center. Post-baseline MRI will be conducted on all participants (surgery/control) within 48 hours of the surgery/pseudo-surgery date to identify acute stroke differences from baseline. Cognitive assessments will be conducted for each participant at three-weeks, three-months, and one-year after surgery.
The research is highly significant because it will be the first study to use in-vivo diffusion imaging methods to examine the contribution of specific presurgical neuroanatomical vulnerabilities on executive and memory cognitive decline after one of the most common orthopedic surgeries sought by older adults. Additionally, it will be the first study to examine how specific neuroimaging biomarkers interact negatively with specific peri-operative variables including emboli number during surgery, embolic changes to the brain, anesthesia depth, and cerebral oxygenation.
The findings of the study will improve pre-surgery screening procedures for older adults and assist with the development of peri-operative interventions that will prevent neurodegenerative disease acceleration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Other: Magnetic Resonance Imaging, Behavioral: Cognitive assessment testing80 patients will undergo total knee replacement surgery; two Magnetic Resonance Imaging scans; cognitive assessment testing. |
| Non-Surgery | – | Other: Magnetic Resonance Imaging, Behavioral: Cognitive assessment testing80 non-surgery participants will be included as part of the control group; two Magnetic Resonance Imaging scans; cognitive assessment testing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two age-matched participant groups will be recruited. Healthy non-demented age matched patients undergoing elective total knee arthoplasty, and age, education, and diseased matched (osteoarthritis knee pain;) non-surgery peers.
Key inclusion criteria (6 listed)
- Planned total unilateral knee antroplasty or non-surgical knee osteoarthritis
- Age 60 years or older at the time of baseline assessment
- Telephone screening and in-person baseline cognitive testing not supportive of dementia
- Handedness: Right handed; restriction to left-right hemisphere laterality and white matter pathways
- Participant and family deny presence of difficulties with Instrumental Activities of Daily Living (IADL)
Key exclusion criteria (24 listed)
- Underlying medical diseases likely to limit lifespan or confound outcome analyses:
- Neurodegenerative Exclusions:
- Psychiatric Exclusions:
- Conditions or behaviors likely to affect imaging or cognitive testing:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRIBoth groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery. | Other | Non-Surgery, Surgery |
| Cognitive assessment testingAlso: Cognitive assessement testsBoth groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year. | Behavioural | Non-Surgery, Surgery |
Primary outcome
Predicting Executive Decline
Time frame: baseline, 3 weeks, 3 months, 1 year
Severity of pre-surgical/baseline neuroimaging markers of cerebrovascular disease will predict post-operative executive decline at 3 weeks, 3 months and 1 year.
Predicting Memory Decline
Time frame: baseline, 3 weeks, 3 months, 1 year
Pre-surgical/baseline neuroimaging markers of entorhinal-hippocampal white matter connectivity will predict post-operative memory decline at 3 weeks, 3 months and 1 year.
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 8 Jul 2019.
- Derived from this study: PubMed 30273231Hizel LP, Warner ED, Wiggins ME, Tanner JJ, Parvataneni H, Davis R, Penney DL, Libon DJ, Tighe P, Garvan CW, Price CC. Clock Drawing Performance Slows for Older Adults After Total Knee Replacement Surgery. Anesth Analg. 2019 Jul;129(1):212-219. doi: 10.1213/ANE.0000000000003735.
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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.
Catherine Price, Ph.D principal investigator
University of Florida
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 Post-Operative Cognitive Decline in Older Adults, run by University of Florida 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 6 inclusion and 24 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 8 Jul 2019. 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?
Predicting Executive Decline (time frame: baseline, 3 weeks, 3 months, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786577, which also lists 1 linked publication.
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 8 Jul 2019.