Clinical trial NCT01606488: Effects of Brain Beta-Amyloid on Postoperative Cognition
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative Cognitive Dysfunction
Postoperative Cognitive Decline
POCD
Alzheimer's disease
Florbetapir F 18 (18F-AV-45)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Alzheimer's Drug Discovery Foundation
name: Avid Radiopharmaceuticals
First posted: 2012-05-25
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.
* Current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject
* Received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
* 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
* 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

Primary outcomes:
measure: Cognitive Decline
timeFrame: At the time of discharge (or at the latest on the 7th postoperative day)
Secondary outcomes:
measure: Genetic Polymorphisms
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Vagus nerve tone assessment
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Inflammatory Markers
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Perioperative Complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Coma Assessment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Hospital Length of Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Postoperative Complications
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Change in Cognition
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Quality of Life
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Mortality
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Pain intensity
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Pain unpleasantness
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
measure: Post-traumatic Stress Disorder symptomatology
timeFrame: Participants will be followed from preoperative baseline to 1 year postoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marek Brzezinski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: