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 August 2014 by Navidea Biopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01886820
First received: June 24, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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
Dementia
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of [18F]NAV4694 injection.
  • Must be able to provide informed consent or assent, and exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI 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).
  • Subjects who have participated in a previous [18F]NAV4694 study may be included in the present study. The MRI and/or [18F]NAV4694 scan do not need to be repeated if they were performed within 12 months prior to inclusion.

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 received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131I) 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.
  • Has any contraindication to MRI examination, e.g., metal implants or phobia as determined by the on-site radiologist performing the scan.
  • 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 ClinicalTrials.gov identifier: NCT01886820

Contacts
Contact: Joanna Shuping, BS +1-614-822-2388 jshuping@navidea.com
Contact: Carley Hartings, MPH +1-614.973.7558 chartings@navidea.com

Locations
United States, Arizona
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Carolyn Liebsack    623-832-6514    Carolyn.Liebsack@bannerhealth.com   
Contact: Michele Caverly    (623) 832-6529    Michele.Caverly@bannerhealth.com   
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    hvanderswag@ucsd.edu   
Principal Investigator: James Brewer, M.D.         
United States, Florida
Mount Sinai Medical Center of Florida Recruiting
Miami Beach, Florida, United States, 33140
Contact: Isael Santos    305-674-2018    Isael.Santos@msmc.com   
Principal Investigator: Ranjan Duara, M.D.         
Galiz Research Recruiting
Miami Springs, Florida, United States, 33166
Contact: Luis Pedraza    305-805-0921    luisp@galizresearch.com   
Principal Investigator: Jose Gamez, M.D.         
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Dan Marsh    407-210-1310    DMarsh@CompassResearch.com   
Principal Investigator: Ira Goodman, M.D.         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Lindsay Pluff    312-563-4111    Lindsay_M_Pluff@rush.edu   
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    blokaitis@siumed.edu   
Principal Investigator: Thomas A Ala, MD         
United States, Nevada
Las Vegas Radiology Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Joanna Bachowska    702-521-8950    joannabachowska@yahoo.com   
Principal Investigator: Bobby Mocherla, M.D.         
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Mark Sollars    718-405-8363    csollars@montefiore.org   
Contact: Khosrow Baigi    (718) 405-8363    krezagho@montefiore.org   
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: Sierra Marino    919-966-8172    smarino@email.unc.edu   
Contact: Teri Swezey    (919) 966-8172    tswezey@neurology.unc.edu   
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    rfries@wakehealth.edu   
Principal Investigator: Kaycee Sink, M.D.         
United States, Ohio
Valley Medical Center Recruiting
Centerville, Ohio, United States, 45459
Contact: Cynthia Whittington    937-208-8298    rncynthia@aol.com   
Principal Investigator: Meenakshi Patel, MD         
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
Study Director: Cornelia Reininger, MD PhD Navidea Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01886820     History of Changes
Other Study ID Numbers: NAV4-02
Study First Received: June 24, 2013
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014