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
NCT ID: NCT01886820
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
290 participants
INTERVENTIONAL
2013-06-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]NAV4694
Intravenous \[18F\]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
[18F]NAV4694
Interventions
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[18F]NAV4694
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Navidea Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Cornelia Reininger, MD PhD
Role: STUDY_DIRECTOR
Navidea Biopharmaceuticals
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California San Diego
La Jolla, California, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States
Galiz Research
Miami Springs, Florida, United States
Compass Research
Orlando, Florida, United States
Physicians Care Clinical Research
Sarasota, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Biomedical Research Foundation
Shreveport, Louisiana, United States
Las Vegas Radiology
Las Vegas, Nevada, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health-Gerontology
Winston-Salem, North Carolina, United States
Valley Medical Center
Centerville, Ohio, United States
Countries
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Other Identifiers
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NAV4-02
Identifier Type: -
Identifier Source: org_study_id
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