A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
1 other identifier
interventional
290
1 country
15
Brief Summary
To Determine the the Efficacy and Safety of \[18F\]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2013
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJuly 26, 2017
July 1, 2017
5 years
June 24, 2013
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
6 Months
Secondary Outcomes (4)
Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology
6 Months
Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
6 Months
Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
6 Months
Incidence of adverse events
6 months
Study Arms (1)
[18F]NAV4694
EXPERIMENTALIntravenous \[18F\]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects will be at least 21 years of age.
- Subjects will have a life expectancy of approximately 6 months
- Subject health is adequate as determined by the investigator to receive \[18F\]NAV4694
- Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of \[18F\]NAV4694 injection.
- Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.
- Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved).
- Subjects have been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (LAR) (for individuals with dementia).
You may not qualify if:
- Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after \[18F\]NAV4694 injection.
- Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs.
- Has any history of any transmissible spongiform encephalopathy (prion disease).
- Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration.
- Is allergic to the investigational product or any of its constituents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of California San Diego
La Jolla, California, 92093, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140, United States
Galiz Research
Miami Springs, Florida, 33166, United States
Compass Research
Orlando, Florida, 32806, United States
Physicians Care Clinical Research
Sarasota, Florida, 34239, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Biomedical Research Foundation
Shreveport, Louisiana, 71103, United States
Las Vegas Radiology
Las Vegas, Nevada, 89113, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559, United States
Wake Forest Baptist Health-Gerontology
Winston-Salem, North Carolina, 27157, United States
Valley Medical Center
Centerville, Ohio, 45459, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cornelia Reininger, MD PhD
Navidea Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
June 26, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2018
Study Completion
September 1, 2018
Last Updated
July 26, 2017
Record last verified: 2017-07