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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01886820
• Other study ID #: NAV4-02
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 24, 2013
• Last updated: July 25, 2017
• Start date: June 2013
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: Navidea Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• [18F]NAV4694

Locations

Country	Name	City	State
United States	Valley Medical Center	Centerville	Ohio
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	University of California San Diego	La Jolla	California
United States	Las Vegas Radiology	Las Vegas	Nevada
United States	Mount Sinai Medical Center of Florida	Miami Beach	Florida
United States	Galiz Research	Miami Springs	Florida
United States	Compass Research	Orlando	Florida
United States	Physicians Care Clinical Research	Sarasota	Florida
United States	Biomedical Research Foundation	Shreveport	Louisiana
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Albert Einstein College of Medicine	The Bronx	New York
United States	Wake Forest Baptist Health-Gerontology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology		6 Months
Secondary	Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology		6 Months
Secondary	Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology		6 Months
Secondary	Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology		6 Months
Secondary	Incidence of adverse events		6 months