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

  Show 32 Study Locations
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