Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
1 other identifier
interventional
79
1 country
22
Brief Summary
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2016
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2017
CompletedResults Posted
Study results publicly available
August 24, 2020
CompletedAugust 24, 2020
August 1, 2020
1.1 years
June 7, 2016
June 27, 2020
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status
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.
18 months
Study Arms (1)
Follow-up Flortaucipir PET Scan
EXPERIMENTALInterventions
370 megabecquerel (MBq) IV single-dose
Eligibility Criteria
You may qualify if:
- Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Imaging Endpoints
Scottsdale, Arizona, 85258, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Institute for Brain Aging and Dementia, UC Irvine
Irvine, California, 92697, United States
21st Century Oncology
Newport Beach, California, 92663, United States
Alzheimer's Disease Center, UC Davis
Sacramento, California, 95817, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, 33613, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Las Vegas Radiology
Las Vegas, Nevada, 89113, United States
New York University Center for Brain Health
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Avid Radiopharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2016
First Posted
June 10, 2016
Study Start
August 1, 2016
Primary Completion
August 28, 2017
Study Completion
August 28, 2017
Last Updated
August 24, 2020
Results First Posted
August 24, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share