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Trial record 3 of 10 for:    navidea

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 currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Navidea Biopharmaceuticals
Information provided by (Responsible Party):
Navidea Biopharmaceuticals Identifier:
First received: June 24, 2013
Last updated: October 24, 2014
Last verified: October 2014

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
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 2016
Estimated Primary Completion Date: June 2015 (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


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01886820

Contact: Diana Demeo, BS +1-614-822-2353
Contact: Carley Hartings, MPH +1-614.973.7558

United States, Arizona
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Carolyn Liebsack    623-832-8790   
Contact: Christina Chong    (623) 832-6529   
Principal Investigator: Marwan Sabbagh, M.D.         
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Helen Vanderswag    858-246-1245   
Principal Investigator: James Brewer, M.D.         
United States, Florida
Neuropsychiatric Research Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
Contact: Melissa Schaerf    239-939-7777   
Principal Investigator: Frederick Schaerf, MD, PhD         
Mount Sinai Medical Center of Florida Recruiting
Miami Beach, Florida, United States, 33140
Contact: Ana Betancourt    305-674-2018   
Principal Investigator: Ranjan Duara, M.D.         
Galiz Research Recruiting
Miami Springs, Florida, United States, 33166
Contact: Luis Pedraza    305-805-0921   
Principal Investigator: Jose Gamez, M.D.         
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Kurt Cicilioni    407-210-1310   
Principal Investigator: Ira Goodman, M.D.         
Physicians Care Clinical Research Recruiting
Sarasota, Florida, United States, 34239
Contact: Jennifer Aranda    941-954-2355   
Principal Investigator: Joseph Ganey, M.D.         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Messenger    312-563-4111   
Principal Investigator: Raj Shah, M.D.         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Barbara C Lokaitis, BA    217-545-9737   
Principal Investigator: Thomas A Ala, MD         
United States, Louisiana
Biomedical Research Foundation Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Kelly Hoffman    318-675-4034   
Principal Investigator: Pradeep Garg, Ph.D         
United States, Nevada
Las Vegas Radiology Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Joanna Bachowska    702-521-8950   
Principal Investigator: Bobby Mocherla, M.D.         
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Khosrow Baigi    718-405-8363   
Principal Investigator: Jessica Zwerling, MD         
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27559
Contact: Teri Swezey    919-966-8172   
Principal Investigator: Daniel Kaufer, M.D.         
Wake Forest Baptist Health-Gerontology Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rose Fries    336-713-8462   
Principal Investigator: Kaycee Sink, M.D.         
United States, Ohio
Valley Medical Center Recruiting
Centerville, Ohio, United States, 45459
Contact: Cynthia Whittington    937-208-8298   
Principal Investigator: Meenakshi Patel, MD         
Sponsors and Collaborators
Navidea Biopharmaceuticals
Study Director: Cornelia Reininger, MD PhD Navidea Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Navidea Biopharmaceuticals Identifier: NCT01886820     History of Changes
Other Study ID Numbers: NAV4-02
Study First Received: June 24, 2013
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 24, 2014