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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

Sponsor
Navidea Biopharmaceuticals (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01886820
Collaborator
(none)
290
Enrollment
15
Locations
1
Arm
63
Anticipated Duration (Months)
19.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
290 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: [18F]NAV4694

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

Drug: [18F]NAV4694

Outcome Measures

Primary Outcome Measures

  1. Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology [6 Months]

Secondary Outcome Measures

  1. Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology [6 Months]

  2. Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [6 Months]

  3. Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology [6 Months]

  4. Incidence of adverse events [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Banner Sun Health Research Institute Sun City Arizona United States 85351
2 University of California San Diego La Jolla California United States 92093
3 Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida United States 33912
4 Mount Sinai Medical Center of Florida Miami Beach Florida United States 33140
5 Galiz Research Miami Springs Florida United States 33166
6 Compass Research Orlando Florida United States 32806
7 Physicians Care Clinical Research Sarasota Florida United States 34239
8 Rush University Medical Center Chicago Illinois United States 60612
9 Southern Illinois University School of Medicine Springfield Illinois United States 62702
10 Biomedical Research Foundation Shreveport Louisiana United States 71103
11 Las Vegas Radiology Las Vegas Nevada United States 89113
12 Albert Einstein College of Medicine The Bronx New York United States 10461
13 The University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27559
14 Wake Forest Baptist Health-Gerontology Winston-Salem North Carolina United States 27157
15 Valley Medical Center Centerville Ohio United States 45459

Sponsors and Collaborators

  • Navidea Biopharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01886820
Other Study ID Numbers:
  • NAV4-02
First Posted:
Jun 26, 2013
Last Update Posted:
Jul 26, 2017
Last Verified:
Jul 1, 2017
Keywords provided by Navidea Biopharmaceuticals
Dementia
Alzheimer's Disease
Terminally Ill
Additional relevant MeSH terms:
Alzheimer Disease
Dementia

Study Results

No Results Posted as of Jul 26, 2017