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

• ClinicalTrials.gov Identifier: NCT01886820
• Recruitment Status: Unknown
• First Posted: June 26, 2013
• Last Update Posted: July 26, 2017
• Sponsor: Navidea Biopharmaceuticals
• Information provided by (Responsible Party): Navidea Biopharmaceuticals

Tracking Information

• First Submitted Date: June 24, 2013
• First Posted Date: June 26, 2013
• Last Update Posted Date: July 26, 2017
• Actual Study Start Date: June 2013
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 25, 2013): Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [ Time Frame: 6 Months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Dementia
• Alzheimer's Disease

• Intervention: Drug: [18F]NAV4694

Study Arms

Experimental: [18F]NAV4694

Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once

Intervention: Drug: [18F]NAV4694

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 25, 2013): 290
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2018
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01886820
• Other Study ID Numbers: NAV4-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Navidea Biopharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Navidea Biopharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Cornelia Reininger, MD PhD; Navidea Biopharmaceuticals

• PRS Account: Navidea Biopharmaceuticals
• Verification Date: July 2017