Effects of Brain Beta-Amyloid on Postoperative Cognition
Effects of Brain Beta-Amyloid on Postoperative Cognition
Overall Status:
Recruiting
Brief Description:
This study will test the hypothesis that the presence of beta-amyloid plaques in the brain--a hallmark of Alzheimer's disease--in non-demented older patients increases the likelihood of cognitive decline after scheduled hip or knee replacement surgery.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | N/A | Both | No |
Inclusion Criteria:
- Scheduled for total knee arthroplasty or total hip arthroplasty under general anesthesia (primary arthroplasties and revisions) with anticipated hospital stay
- English speaking
- Regular visits from an individual willing to provide information about the patient's cognitive status
- Adequate seeing and hearing ability to allow neuropsychological testing
- Clinical Dementia Rating Scale (CDR) score of 0-0.5 (no dementia)
Exclusion Criteria:
- Dementia of any cause; CDR score of > 0.5; obvious cause of cognitive impairment such as recent head trauma or stroke
- Preference to undergo hip or knee replacement surgery under regional anesthesia in the form of spinal or epidural anesthesia
- Expectation of staying intubated postoperatively
- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances, which might pose a potential safety risk to the participant
- Current clinically significant cardiovascular disease or other medical disease that might pose a safety risk to the participant
- History of drug or alcohol abuse within the last year or prior prolonged history of abuse
- Severe psychiatric disorders, including schizophrenia, bipolar disorders, or major depression
- Clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive test for hepatitis
- History of relevant severe drug allergy or hypersensitivity
- Received an investigational medication under an FDA investigational new drug study within the last 30 days; received a radiopharmaceutical for imaging or therapy within 24 hours before this study's imaging session
Detailed Description:
Cognitive decline after surgery affects up to half of all noncardiac surgical patients who are 65 years old or older. This study will test the hypothesis that the presence of beta-amyloid plaques in the brain--a hallmark of Alzheimer's disease--in non-demented older patients increases the likelihood of cognitive decline after scheduled hip or knee replacement surgery. One injection of florbetapir F18 (18F-AV-45), an imaging agent, will be given approximately 50 minutes prior to a 10-minute PET scan of the brain.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 37.7813454, -122.497668 | San Francisco VA Medical Center | San Francisco | California | 94121 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University of California, San Francisco |
Collaborator Sponsor:
| Agency |
|---|
Alzheimer’s Drug Discovery Foundation |
Avid Radiopharmaceuticals |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Marek Brzezinski, MD, PhD | Principal Investigator | University of California, San Francisco |
Study Contact:
| Name | Phone | |
|---|---|---|
Marek Brzezinski, MD, PhD | 877-487-2838 |
Locations
ClinicalTrials.gov ID
NCT01606488 (follow link to view full record on ct.gov in new window)
Official Title:
Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Study Start Date:
May 2012
Study End Date:
April 2014
Enrollment:
65
