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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

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE June 26, 2013
Last Update Posted Date July 26, 2017
Actual Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Dementia
  • Alzheimer's Disease
Intervention  ICMJE Drug: [18F]NAV4694
Study Arms  ICMJE Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
Intervention: Drug: [18F]NAV4694
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01886820
Other Study ID Numbers  ICMJE NAV4-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navidea Biopharmaceuticals
Study Sponsor  ICMJE Navidea Biopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cornelia Reininger, MD PhD Navidea Biopharmaceuticals
PRS Account Navidea Biopharmaceuticals
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP