NCT01606488Active, not recruitingPhase 4
Effects of Brain Beta-Amyloid on Postoperative Cognition
Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 23 May 2012
- Start date
- May 2012
- Primary completion date
- Jun 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- Alzheimer disease
- NCT number
- NCT01606488
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 66
- From May 2012 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Received an investigational medication under an FDA IND protocol within the last 30 days.
- Received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Other illness
- Current clinically significant cardiovascular disease.
- History of relevant severe drug allergy or hypersensitivity
- Severe psychiatric disorders including schizophrenia, bipolar disorders, and major depression as described in DSM-IV within the past year (medical record, GDS score, interview with the patient and study partner)
- Obvious causes for their cognitive impairment (e.g. onset coincides with recent head trauma or stroke)
- Dementia of any cause
Other
- 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 unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject
- CDR score \> 0.5
- Expressed the preference to undergo the procedure under regional anesthesia in form of spinal or epidural anesthesia
- Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Francisco VA Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.