Effects of Brain Beta-Amyloid on Postoperative Cognition (NCT01606488) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effects of Brain Beta-Amyloid on Postoperative Cognition
United States66 participantsStarted 2012-05
Plain-language summary
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.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
* Scheduled for total knee arthroplasty or total hip arthroplasty under general anesthesia (primary arthroplasties and revisions)
* English speaking
* Anticipated stay in the hospital
* Not anticipated to stay intubated postoperatively
* Patients who live with or have regular visits from an individual ("study partner") willing to provide information about the patient's cognitive status
* Willing and able to undergo all testing procedures including neuroimaging and agree to longitudinal follow up
* Adequate visual and auditory acuity to allow neuropsychological testing
* Subjects with Clinical Dementia Rating Scale (CDR) of 0-0.5
* Patients who are not demented
* Subjects sho signed an IRB approved informed consent prior to any study procedures
Exclusion Criteria:
* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject
* Current clinically significant cardiovascular disease.
* History of drug or alcohol abuse within the last year, or prior prolonged history of abuse
* Clinically significant infections 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 IND protocol within the last 30 days.
* Curren…
What they're measuring
1
Cognitive Decline
Timeframe: At the time of discharge (or at the latest on the 7th postoperative day)