Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
- Registration Number
- NCT02795780
- Lead Sponsor
- Avid Radiopharmaceuticals
- Brief Summary
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study
- Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- Have received or participated in a trial with investigational medications in the past 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Follow-up Flortaucipir PET Scan PET Scan - Follow-up Flortaucipir PET Scan Flortaucipir F18 -
- Primary Outcome Measures
Name Time Method Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status 18 months Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Institute for Brain Aging and Dementia, UC Irvine
🇺🇸Irvine, California, United States
California Medical Clinic for Headache
🇺🇸Santa Monica, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Imaging Endpoints
🇺🇸Scottsdale, Arizona, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Las Vegas Radiology
🇺🇸Las Vegas, Nevada, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
New York University Center for Brain Health
🇺🇸New York, New York, United States
21st Century Oncology
🇺🇸Newport Beach, California, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Alzheimer's Disease Center, UC Davis
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
University of South Florida Health Byrd Alzheimer's Institute
🇺🇸Tampa, Florida, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States