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PET Imaging Agent [18F]NAV4694 for Detecting Cerebral Beta-Amyloid

Active, not recruiting

This Phase III study will determine the efficacy and safety of the agent [18F]NAV4694 used in positron emission tomography (PET) brain imaging. The test is designed to detect beta-amyloid, a protein commonly found in the brains of people with Alzheimer's disease. Participants must have a life expectancy of about 6 months.

Minimum Age Maximum Age Gender Healthy Volunteers
21 Years N/A Both No
June 2013
December 2016
290

  • Life expectancy of approximately 6 months
  • Ability to provide informed consent and exhibit adequate visual, auditory, and communication capabilities, including the ability to lie flat in an MRI or PET scanner for about 1 hour
  • Willingness to donate brain for post mortem examination upon death
  • MRI and/or [18F]NAV4694 scans do not need to be repeated if performed within 12 months prior to this study

  • Female subjects of child-bearing potential or with a positive urine pregnancy test on the day of [18F]NAV4694 injection
  • Scheduled for surgery and/or another invasive procedure within 7 days after [18F]NAV4694 injection
  • Severe cerebral macrovascular disease or brain tumor
  • Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to receiving the investigational agent
  • Has received a therapeutic radiopharmaceutical (for example, 131I) within 10 days prior to receiving the investigatonal agent
  • Any radiopharmaceutical administration within 10 radioactive half-lives prior to receiving the investigational agent or planned within 7 days after receiving the agent
  • Contraindication to MRI examination, such as metal implants or phobia
  • Allergy to investigational product or any of its ingredients

Investigators will compare the results of brain imaging with [18F]NAV4694 PET with the results of autopsy to determine the agent's ability to detect beta-amyloid in certain brain regions and enable earlier identification of Alzheimer's disease and monitoring of disease progression. NAV4694 is a fluorine-18 labeled precision radiopharmaceutical candidate, used in PET imaging to evaluate people with signs or symptoms of cognitive impairment such as Alzheimer's disease. NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans.

Name City State Zip Status Primary Contact
Banner Sun Health Research Institute
Sun City Arizona 85351

University of California San Diego
La Jolla California 92093

Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912

Mount Sinai Medical Center of Florida
Miami Beach Florida 33140

Galiz Research
Miami Springs Florida 33166

Compass Research
Orlando Florida 32806

Physicians Care Clinical Research
Sarasota Florida 34239

Rush University Medical Center
Chicago Illinois 60612

Southern Illinois University School of Medicine
Springfield Illinois 62702

Biomedical Research Foundation
Shreveport Louisiana 71103

Las Vegas Radiology
Las Vegas Nevada 89113

Albert Einstein College of Medicine
The Bronx New York 10461

The University of North Carolina at Chapel Hill
Chapel Hill North Carolina 27559

Wake Forest Baptist Health-Gerontology
Winston-Salem North Carolina 27157

Valley Medical Center
Centerville Ohio 45459

Navidea Biopharmaceuticals

Name Role Affiliation
Cornelia Reininger, MD, PhD Study Director Navidea Biopharmaceuticals

Name Phone Email
Joanna Shuping 614-822-2388 jshuping@navidea.com

NCT01886820

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