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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01886820
First received: June 24, 2013
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Navidea Biopharmaceuticals:

Primary Outcome Measures:
  • Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
Drug: [18F]NAV4694

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886820

Locations
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
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
Study Director: Cornelia Reininger, MD PhD Navidea Biopharmaceuticals
  More Information

Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01886820     History of Changes
Other Study ID Numbers: NAV4-02 
Study First Received: June 24, 2013
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Navidea Biopharmaceuticals:
Dementia
Alzheimer's Disease
Terminally Ill

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 30, 2016