This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01518374
First received: July 20, 2011
Last updated: June 9, 2017
Last verified: June 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    Adverse event frequency related to florbetapir administration


Secondary Outcome Measures:
  • Florbetapir F 18 tracer uptake as determined by SUVR [ Time Frame: 0-90 minutes ]
    SUVR=standard uptake value ratio


Enrollment: 1772
Study Start Date: December 2009
Study Completion Date: May 3, 2017
Primary Completion Date: May 3, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Arizona
Banner Health
Phoenix, Arizona, United States, 85006
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
UC Davis
Davis, California, United States, 95618
UC Irvine
Irvine, California, United States, 92697
University of Southern California
Los Angeles, California, United States, 90033
UC Irvine
Orange, California, United States, 92868
UC San Francisco
San Francisco, California, United States, 94121
UC San Francisco Memory Center
San Francisco, California, United States, 94143
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32254
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27104
United States, Pennsylvania
Jefferson
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37920
Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
UTSW
Dallas, Texas, United States, 75231
UTSW
Dallas, Texas, United States, 75235
UTSW
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

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: June 9, 2017

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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017