Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Overall Status:
Recruiting
Brief Description:
This study is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies, such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
18 Years | N/A | Both | Yes |
Inclusion Criteria:
- At least 18 years of age
- Ability to tolerate the PET scan procedures
Exclusion Criteria:
- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine conditions
- Clinically significant cardiovascular disease, such as cardiac surgery or myocardial infarction within the last 4 weeks, unstable angina, significant cardiac arrhythmia or conduction disturbance, uncontrolled high blood pressure
- 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 or breastfeeding
- History of relevant severe drug allergy or hypersensitivity, as determined by investigators
- Taking of an investigational medication under an FDA IND protocol within the last 30 days
- Unstable medical comorbidities that pose a potential safety risk to the subject
- Radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study unless the trial sponsor has approved it
Detailed Description:
None
Central Contact Information:
For more information about individual study sites, contact Avid Clinical Operations: call 1-215-298-0700 or e-mail clinicaloperations@avidrp.com.
Locations:
| Map Marker | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 0, 0 | Site | Phoenix | Arizona | 85006 | Completed |
Geolocation is 0, 0 | Site | Phoenix | Arizona | 85006 | Recruiting |
Geolocation is 0, 0 | Site | Sun City | Arizona | 85351 | Completed |
Geolocation is 0, 0 | Site | Irvine | California | 92697 | Completed |
Geolocation is 0, 0 | Site | Los Angeles | California | 90033 | Recruiting |
Geolocation is 0, 0 | Site | Orange | California | 92868 | Recruiting |
Geolocation is 0, 0 | Site | San Francisco | California | 94121 | Completed |
Geolocation is 0, 0 | Site | San Francisco | California | 94121 | Recruiting |
Geolocation is 0, 0 | Site | San Francisco | California | 94143 | Recruiting |
Geolocation is 0, 0 | Site | Jacksonville | Florida | 32254 | Recruiting |
Geolocation is 0, 0 | Site | Miami Beach | Florida | 33140 | Recruiting |
Geolocation is 0, 0 | Site | Chicago | Illinois | 60611 | Recruiting |
Geolocation is 0, 0 | Site | Kansas City | Kansas | 66160 | Recruiting |
Geolocation is 0, 0 | Site | Baltimore | Maryland | 21287 | Completed |
Geolocation is 0, 0 | Site | Baltimore | Maryland | 21287 | Recruiting |
Geolocation is 0, 0 | Site | Boston | Massachusetts | 02114 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Avid Radiopharmaceuticals |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Chief Medical Officer | Study Director | Avid Radiopharmaceuticals |
Study Contact:
| Name | Phone | |
|---|---|---|
Avid Clinical Operations | 215-298-0700 |
Locations
ClinicalTrials.gov ID
NCT01518374 (follow link to view full record on ct.gov in new window)
Official Title:
Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Study Start Date:
December 2009
Study End Date:
December 2015
Enrollment:
600
