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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive Decline
Timeframe: At the time of discharge (or at the latest on the 7th postoperative day)