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Effects of Brain Beta-Amyloid on Postoperative Cognition

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborators:
Alzheimer’s Drug Discovery Foundation
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Marek Brzezinski, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01606488
First received: May 23, 2012
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Cognitive Dysfunction
 Drug: Florbetapir F 18 (18F-AV-45)
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Cognitive Decline [ Time Frame: At the time of discharge (or at the latest on the 7th postoperative day) ] [ Designated as safety issue: No ]
    Measured using comprehensive neurocognitive test battery


Secondary Outcome Measures:
  • Genetic Polymorphisms [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured by obtaining blood sample

  • Vagus nerve tone assessment [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using Heart Rate Variability (HRV)

  • Inflammatory Markers [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured by obtaining blood samples

  • Perioperative Complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: No ]
    Measured using patient medical records

  • Delirium [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: No ]
    Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit

  • Coma Assessment [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: No ]
    Measured using the Richmond Agitation Sedation Scale (RASS)

  • Hospital Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: No ]
    Measured using patient medical records

  • Postoperative Complications [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using patient medical records

  • Change in Cognition [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using comprehensive neurocognitive test battery

  • Quality of Life [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale

  • Mortality [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using patient medical records

  • Pain intensity [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using the Numerical Rating Scale

  • Pain unpleasantness [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using the Numerical Rating Scale

  • Post-traumatic Stress Disorder symptomatology [ Time Frame: Participants will be followed from preoperative baseline to 1 year postoperative ] [ Designated as safety issue: No ]
    Measured using the PTSD Checklist


Estimated Enrollment: 65
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Florbetapir F 18 (18F-AV-45)
    Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan.
    Other Names:
    • Florbetapir
    • Amyvid 18F-AV-45
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606488

Contacts
Contact: Marek Brzezinski, MD, PhD 877-487-2838 brzezinm@anesthesia.ucsf.edu
Contact: Maren Gregersen 415-221-4810 ext 4385 gregersenm@anesthesia.ucsf.edu

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Marek Brzezinski, MD, PhD            
Sub-Investigator: Kim Hubert, MD, PhD            
Sub-Investigator: Carina Mari Aparici, MD            
Sub-Investigator: Michael Weiner, MD            
Sub-Investigator: John Kornak, PhD            
Sub-Investigator: Joel H Kramer, PsyD            
Sub-Investigator: Mervyn Maze, MB, ChB            
Sponsors and Collaborators
University of California, San Francisco
Alzheimer’s Drug Discovery Foundation
Avid Radiopharmaceuticals
Investigators
Principal Investigator: Marek Brzezinski, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Marek Brzezinski, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01606488     History of Changes
Other Study ID Numbers: 20110506, 18F-AV-45-A14
Study First Received: May 23, 2012
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Postoperative Cognitive Dysfunction
Postoperative Cognitive Decline
POCD
Alzheimer's disease
Florbetapir F 18 (18F-AV-45)

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013