Alzheimer's Disease Education and Referral Center

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 AgeMax AgeGenderHealthy Volunteers
65 Years
N/A
Both
No
Inclusion Criteria: 
    • Scheduled for total knee or hip replacement 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. All participants will undergo neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers. The treatment group will also undergo a PET brain imaging scan with florbetapir F18 (18F-AV-45), an imaging agent; the control group will not.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 37.7813454, -122.497668

Site
San Francisco
California
94121
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
University of California, San Francisco
Collaborator Sponsor: 
Agency
Alzheimer’s Drug Discovery Foundation
Avid Radiopharmaceuticals
Facility Investigators: 
NameRoleAffiliation
Marek Brzezinski, MD, PhD
Principal Investigator
University of California, San Francisco
Study Contact: 
NamePhonePhone ExtEmail
Marek Brzezinski, MD, PhD
877-487-2838
Maren Gregersen
415-221-4810
4385
Locations
 
 
ClinicalTrials.gov ID 
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 2015
Enrollment: 
65