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

July 25, 2017 updated by: Navidea Biopharmaceuticals
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center of Florida
      • Miami Springs, Florida, United States, 33166
        • Galiz Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Sarasota, Florida, United States, 34239
        • Physicians Care Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Biomedical Research Foundation
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Radiology
    • New York
      • The Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27559
        • The University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health-Gerontology
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once
Drug: [18F]NAV4694

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology
Time Frame: 6 Months
6 Months
Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Time Frame: 6 Months
6 Months
Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Time Frame: 6 Months
6 Months
Incidence of adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navidea Biopharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAV4-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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