Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Avid Radiopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01518374
First received: July 20, 2011
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

This protocol is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies (companion protocol) such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases.


Condition Intervention Phase
Alzheimer Disease
Mild Cognitive Impairment
Neurodegenerative Diseases
Drug: Florbetapir F 18
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Adverse event frequency related to florbetapir administration


Secondary Outcome Measures:
  • Florbetapir F 18 tracer uptake as determined by SUVR [ Time Frame: 0-90 minutes ] [ Designated as safety issue: No ]
    SUVR=standard uptake value ratio


Estimated Enrollment: 1800
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Florbetapir-PET Scans Drug: Florbetapir F 18
370 MBq (10 mCi)
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Subjects who meet all of the following criteria are eligible to enroll in this study:

  1. Male or female subjects at least 18 years of age;
  2. Subjects who sign an IRB approved informed consent prior to any study procedures. Where subjects are deemed incapable of informed consent, a legally authorized representative may provide consent, with the subject's documented assent; and
  3. Subjects who in the opinion of the investigator can tolerate the PET scan procedures.

Subjects will be excluded from enrollment if they:

  1. Have 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;
  2. Have current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:

    • cardiac surgery or myocardial infarction within the last 4 weeks;
    • unstable angina;
    • acute decompensated congestive heart failure or class IV heart failure;
    • current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope;
    • uncontrolled high blood pressure; or
    • QTc > 450 msec (by history or for patients with cardiac disease by screening evaluation in companion study)

    Before enrolling a patient with any of the above conditions, the investigator must have performed a cardiac evaluation and obtain permission from the sponsor.

  3. Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse;
  4. Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging) or breastfeeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Florbetapir F 18 Injection ( such as oral contraceptives for at least three months or an IUD for at least two months prior to the start of the screening visit, or various barrier methods, e.g., diaphragm or combination condom and spermicide);
  5. Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe drug allergies should be determined by the PI, and any questions about a subject's eligibility can be directed to Avid. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study);
  6. Are patients who have received an investigational medication under an FDA IND protocol within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. Patients who have ever participated in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be enrolled without prior sponsor approval unless it can be demonstrated that the patient received only placebo in the course of the trial;
  7. Are patients with current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject.
  8. Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study. If another radiotracer is required in the companion protocol, patients may be able to receive a radiopharmaceutical for imaging or therapy within the 24 hours prior to the imaging session with prior sponsor approval and at the discretion of the investigator.; and
  9. Are patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.

If at the time of enrollment subjects do not meet all eligibility criteria, the subjects may still be enrolled if documentation is provided demonstrating that the subject will meet all criteria at the time of the first imaging procedure.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518374

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

  Hide Study Locations
Locations
United States, Arizona
Banner Health Completed
Phoenix, Arizona, United States, 85006
Banner Health Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-839-6999      
Principal Investigator: Eric Reiman         
Banner Sun Health Research Institute Completed
Sun City, Arizona, United States, 85351
United States, California
UC Davis Recruiting
Davis, California, United States, 95618
Contact    916-734-5223      
Principal Investigator: Owen Carmichael         
UC Irvine Completed
Irvine, California, United States, 92697
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact    323-865-9949      
Principal Investigator: Helena Chui         
UC Irvine Recruiting
Orange, California, United States, 92868
Contact    714-456-8443      
Principal Investigator: Ira Lott         
UC San Francisco Recruiting
San Francisco, California, United States, 94121
Contact    415-221-4810 ext 3851      
Principal Investigator: Thomas Neylan         
UC San Francisco Completed
San Francisco, California, United States, 94121
UC San Francisco Memory Center Recruiting
San Francisco, California, United States, 94143
Contact    415-514-2374      
Principal Investigator: Gil Rabinovici         
UC San Francisco Recruiting
San Francisco, California, United States, 94121
Contact    415-221-4810 ext 4593      
Principal Investigator: Michael Weiner         
UC San Francisco Recruiting
San Francisco, California, United States, 94121
Contact    415-750-2069      
Principal Investigator: Marek Brzezinski         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32254
Contact    904-953-7103      
Principal Investigator: Neill Graff-Radford         
Mt. Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact    305-674-2543      
Principal Investigator: Ranjan Duara         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact    312-503-1155      
Principal Investigator: Emily Rogalski         
United States, Kansas
University of Kansas Completed
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact    410-614-2381      
Principal Investigator: Rebecca Gottesman         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact    410-955-8433      
Principal Investigator: Dean Wong         
Johns Hopkins University Completed
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact    617-726-5362      
Principal Investigator: Edip Gurol         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact    601-984-5603      
Principal Investigator: Thomas Mosley         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact    314-362-5950      
Principal Investigator: Tammie Benzinger         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact    314-362-7845      
Principal Investigator: Brian Day         
United States, North Carolina
Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Completed
Winston-Salem, North Carolina, United States, 27104
United States, Pennsylvania
Jefferson Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-503-3423      
Principal Investigator: Andrew Newberg         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-455-6403      
Principal Investigator: Stephen Salloway         
United States, Tennessee
University of Tennessee Completed
Knoxville, Tennessee, United States, 37920
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact    615-936-3395      
Principal Investigator: Wesley Ely         
United States, Texas
UTSW Recruiting
Dallas, Texas, United States, 75235
Contact    972-883-3255      
Principal Investigator: Denise Park         
UTSW Recruiting
Dallas, Texas, United States, 75231
Contact    214-345-8843      
Principal Investigator: Rong Zhang         
UTSW Recruiting
Dallas, Texas, United States, 75390
Contact    214-648-0499      
Principal Investigator: Joshua Gatson         
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01518374     History of Changes
Other Study ID Numbers: 18F-AV-45-A14
Study First Received: July 20, 2011
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:
Male or female subjects at least 18 years of age
AD
MCI

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014