Post-Operative Cognitive Decline in Older Adults Clinical Trial
— POCDOfficial title:
Neuroimaging Biomarkers for Post-Operative Cognitive Decline in Older Adults
Verified date | July 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | July 21, 2018 |
Est. primary completion date | June 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Underlying medical diseases likely to limit lifespan or confound outcome analyses: 1. cancer requiring treatment in past five years 2. serious infectious diseases 3. congestive heart failure 4. chronic hepatitis 5. history of organ transplantation 6. seizure disorders 7. history of head trauma resulting in intensive care 8. current diagnosis of alcoholism, drug dependence, history of major tranquilizer use - Neurodegenerative Exclusions: 1. history of major stroke 2. exposure to toxins or neuroleptics 3. history of encephalitis 4. neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear palsy, or significant orthostatic hypertension 5. signs of dementia. - Psychiatric Exclusions: 1. major psychiatric disorder 2. major depression - Conditions or behaviors likely to affect imaging or cognitive testing: 1. claustrophobia 2. non-medical bodily metal, pace-maker device 3. less than five years of formal education 4. inability to read or write 5. self-reported hearing difficulty that interferes with standardized test administration |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Institute of Nursing Research (NINR), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline, 3 weeks, 3 months, 1 year | |
Primary | 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. | baseline, 3 weeks, 3 months, 1 year |