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
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|ClinicalTrials.gov Identifier: NCT01886820|
Recruitment Status : Unknown
Verified July 2017 by Navidea Biopharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : June 26, 2013
Last Update Posted : July 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer's Disease||Drug: [18F]NAV4694||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
- Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [ Time Frame: 6 Months ]
- Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology [ Time Frame: 6 Months ]
- Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ]
- Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ]
- Incidence of adverse events [ Time Frame: 6 months ]
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886820
|United States, Arizona|
|Banner Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|United States, Florida|
|Neuropsychiatric Research Center of Southwest Florida|
|Fort Myers, Florida, United States, 33912|
|Mount Sinai Medical Center of Florida|
|Miami Beach, Florida, United States, 33140|
|Miami Springs, Florida, United States, 33166|
|Orlando, Florida, United States, 32806|
|Physicians Care Clinical Research|
|Sarasota, Florida, United States, 34239|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|United States, Louisiana|
|Biomedical Research Foundation|
|Shreveport, Louisiana, United States, 71103|
|United States, Nevada|
|Las Vegas Radiology|
|Las Vegas, Nevada, United States, 89113|
|United States, New York|
|Albert Einstein College of Medicine|
|The Bronx, New York, United States, 10461|
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27559|
|Wake Forest Baptist Health-Gerontology|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Valley Medical Center|
|Centerville, Ohio, United States, 45459|
|Study Director:||Cornelia Reininger, MD PhD||Navidea Biopharmaceuticals|
|Responsible Party:||Navidea Biopharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||June 26, 2013 Key Record Dates|
|Last Update Posted:||July 26, 2017|
|Last Verified:||July 2017|
Central Nervous System Diseases
Nervous System Diseases