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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals

Study Description
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Brief Summary:
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Drug: [18F]NAV4694 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
 Drug: [18F]NAV4694


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology [ Time Frame: 6 Months ]
  2. Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ]
  3. Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ]
  4. Incidence of adverse events [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Galiz Research
Miami Springs, Florida, United States, 33166
Compass Research
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
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
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Study Director: Cornelia Reininger, MD PhD Navidea Biopharmaceuticals
More Information
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Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01886820    
Other Study ID Numbers: NAV4-02
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Navidea Biopharmaceuticals:
Dementia
Alzheimer's Disease
Terminally Ill
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders