Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 18F-AV-45-A14 | Other Identifier | Avid Radiopharmaceuticals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alzheimer's Drug Discovery Foundation | OTHER |
| Avid Radiopharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients greater than or equal to 65 years of age.
This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects scheduled for hip or knee replacement.
The investigators hypothesize that preoperative beta-amyloid plaques will predict postoperative cognitive decline.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Group | Other | Subjects scheduled to undergo total knee or total hip replacement at the SFVAMC. Subjects in this arm of the study will undergo the florbetapir PET scan once prior to their surgery. Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers. |
|
| Non-surgical group | Other | Subjects being seen in at the SFVAMC orthopedic clinic for knee or hip pain but are not anticipating surgical intervention. Subjects in this arm will not undergo the florbetapir PET scan. Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetapir F 18 (18F-AV-45) | Drug | Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Decline | Measured using comprehensive neurocognitive test battery | At the time of discharge (or at the latest on the 7th postoperative day) |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic Polymorphisms | Measured by obtaining blood sample | Participants will be followed from preoperative baseline to 1 year postoperative |
| Vagus nerve tone assessment | Measured using Heart Rate Variability (HRV) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marek Brzezinski, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
Not provided
Not provided
| ID | Term |
|---|---|
| C545186 | florbetapir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| no intervention | Other |
|
| Participants will be followed from preoperative baseline to 1 year postoperative |
| Inflammatory Markers | Measured by obtaining blood samples | Participants will be followed from preoperative baseline to 1 year postoperative |
| Perioperative Complications | Measured using patient medical records | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Delirium | Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Coma Assessment | Measured using the Richmond Agitation Sedation Scale (RASS) | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Hospital Length of Stay | Measured using patient medical records | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Postoperative Complications | Measured using patient medical records | Participants will be followed from preoperative baseline to 1 year postoperative |
| Change in Cognition | Measured using comprehensive neurocognitive test battery | Participants will be followed from preoperative baseline to 1 year postoperative |
| Quality of Life | Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale | Participants will be followed from preoperative baseline to 1 year postoperative |
| Mortality | Measured using patient medical records | Participants will be followed from preoperative baseline to 1 year postoperative |
| Pain intensity | Measured using the Numerical Rating Scale | Participants will be followed from preoperative baseline to 1 year postoperative |
| Pain unpleasantness | Measured using the Numerical Rating Scale | Participants will be followed from preoperative baseline to 1 year postoperative |
| Post-traumatic Stress Disorder symptomatology | Measured using the PTSD Checklist | Participants will be followed from preoperative baseline to 1 year postoperative |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |