Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dementia
Alzheimer's Disease
Keywords: Dementia
Alzheimer's Disease
Terminally Ill
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 290
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility 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
* 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.

Primary outcomes:
measure: Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
timeFrame: 6 Months
Secondary outcomes:
measure: Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology
timeFrame: 6 Months
measure: Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
timeFrame: 6 Months
measure: Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
timeFrame: 6 Months
measure: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Sarasota
country: United States
facility: Physicians Care Clinical Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Shreveport
country: United States
facility: Biomedical Research Foundation
state: Louisiana
city: Las Vegas
country: United States
facility: Las Vegas Radiology
state: Nevada
city: The Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health-Gerontology
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Center
state: Ohio
Study officials:
affiliation: Navidea Biopharmaceuticals
name: Cornelia Reininger, MD PhD
role: STUDY_DIRECTOR
References: