- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518374
Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Banner Health
-
Sun City, Arizona, United States, 85351
- Banner Sun Health Research Institute
-
-
California
-
Davis, California, United States, 95618
- UC Davis
-
Irvine, California, United States, 92697
- UC Irvine
-
Los Angeles, California, United States, 90033
- University of Southern California
-
Orange, California, United States, 92868
- UC Irvine
-
San Francisco, California, United States, 94121
- UC San Francisco
-
San Francisco, California, United States, 94143
- UC San Francisco Memory Center
-
-
Florida
-
Jacksonville, Florida, United States, 32254
- Mayo Clinic Jacksonville
-
Miami Beach, Florida, United States, 33140
- Mt. Sinai Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
Winston-Salem, North Carolina, United States, 27104
- Wake Forest University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- University of Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Jefferson
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
- University of Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt
-
-
Texas
-
Dallas, Texas, United States, 75390
- UTSW
-
Dallas, Texas, United States, 75231
- UTSW
-
Dallas, Texas, United States, 75235
- UTSW
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Subjects who meet all of the following criteria are eligible to enroll in this study:
- Male or female subjects at least 18 years of age;
- 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
- Subjects who in the opinion of the investigator can tolerate the PET scan procedures.
Subjects will be excluded from enrollment if they:
- 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;
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.
- Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse;
- 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);
- 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);
- 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;
- 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.
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Florbetapir-PET Scans
|
370 MBq (10 mCi)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration
Time Frame: 48 hours
|
Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below) |
48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-AV-45-A14 (Avid Radiopharmaceuticals)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurodegenerative Diseases
-
University Hospital, Strasbourg, FranceRecruitingNeurodegenerative DisordersFrance
-
First Affiliated Hospital of Fujian Medical UniversityRecruitingNeurodegenerative DisordersChina
-
University of PennsylvaniaAvid RadiopharmaceuticalsRecruiting
-
Fujian Medical University Union HospitalRecruitingNeurodegenerative DisordersChina
-
Imperial College LondonWithdrawn
-
Fujian Medical University Union HospitalRecruitingNeurodegenerative DisorderChina
-
ACADIA Pharmaceuticals Inc.CompletedNeuropsychiatric Symptoms Related to Neurodegenerative DiseaseUnited States, Russian Federation, Serbia, Poland, Georgia, Czechia, Bulgaria, Colombia, Mexico, Romania, South Africa, Ukraine
-
ACADIA Pharmaceuticals Inc.CompletedNeuropsychiatric Symptoms Related to Neurodegenerative DiseaseSerbia, United States, Poland, Georgia, Russian Federation, Bulgaria, Colombia, Czechia, Mexico, Romania, South Africa, Ukraine
-
National Institute of Neurological Disorders and...Completed
-
Istituto Auxologico ItalianoRecruitingNeurodegenerative DiseasesItaly
Clinical Trials on Florbetapir F 18
-
Brigham and Women's HospitalTerminatedCardiac AmyloidosisUnited States
-
Avid RadiopharmaceuticalsWithdrawnAlzheimer's DiseaseJapan
-
Avid RadiopharmaceuticalsCompletedProgressive Cognitive DeclineUnited States
-
Avid RadiopharmaceuticalsNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedParkinson's DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedAlzheimer's Disease
-
Avid RadiopharmaceuticalsCompletedMild Cognitive Impairment | Alzheimer's DiseaseUnited States
-
Avid RadiopharmaceuticalsCompletedNeurodegenerative Diseases | Alzheimer Disease | Mild Cognitive Impairment
-
Avid RadiopharmaceuticalsCompletedAlzheimer's Disease
-
Avid RadiopharmaceuticalsCompletedAlzheimer's DiseaseUnited States