Alzheimer's Disease Education and Referral Center

PET Imaging Agent [18F]NAV4694 for Detecting Cerebral Beta-Amyloid

PET Imaging Agent [18F]NAV4694 for Detecting Cerebral Beta-Amyloid

Overall Status: 
Active, not recruiting
Brief Description: 

This Phase III study will determine the efficacy and safety of the agent [18F]NAV4694 used in positron emission tomography (PET) brain imaging. The test is designed to detect beta-amyloid, a protein commonly found in the brains of people with Alzheimer's disease. Participants must have a life expectancy of about 6 months.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
21 Years
N/A
Both
No
Inclusion Criteria: 
    • Life expectancy of approximately 6 months
    • Ability to provide informed consent and exhibit adequate visual, auditory, and communication capabilities, including the ability to lie flat in an MRI or PET scanner for about 1 hour
    • Willingness to donate brain for post mortem examination upon death
    • MRI and/or [18F]NAV4694 scans do not need to be repeated if performed within 12 months prior to this study
Exclusion Criteria: 
    • Female subjects of child-bearing potential or with a positive urine pregnancy test on the day of [18F]NAV4694 injection
    • Scheduled for surgery and/or another invasive procedure within 7 days after [18F]NAV4694 injection
    • Severe cerebral macrovascular disease or brain tumor
    • Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to receiving the investigational agent
    • Has received a therapeutic radiopharmaceutical (for example, 131I) within 10 days prior to receiving the investigatonal agent
    • Any radiopharmaceutical administration within 10 radioactive half-lives prior to receiving the investigational agent or planned within 7 days after receiving the agent
    • Contraindication to MRI examination, such as metal implants or phobia
    • Allergy to investigational product or any of its ingredients
Detailed Description: 

Investigators will compare the results of brain imaging with [18F]NAV4694 PET with the results of autopsy to determine the agent's ability to detect beta-amyloid in certain brain regions and enable earlier identification of Alzheimer's disease and monitoring of disease progression. NAV4694 is a fluorine-18 labeled precision radiopharmaceutical candidate, used in PET imaging to evaluate people with signs or symptoms of cognitive impairment such as Alzheimer's disease. NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans.

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 33.6020658, -112.280129

Banner Sun Health Research Institute
Sun City
Arizona
85351
n/a

Geolocation is 32.8843552, -117.2338066

University of California San Diego
La Jolla
California
92093
n/a

Geolocation is 26.5273497, -81.8333656

Neuropsychiatric Research Center of Southwest Florida
Fort Myers
Florida
33912
n/a

Geolocation is 25.8176795, -80.1372757

Mount Sinai Medical Center of Florida
Miami Beach
Florida
33140
n/a

Geolocation is 25.8223198, -80.289495

Galiz Research
Miami Springs
Florida
33166
n/a

Geolocation is 28.5085825, -81.3564411

Compass Research
Orlando
Florida
32806
n/a

Geolocation is 27.3086034, -82.5239953

Physicians Care Clinical Research
Sarasota
Florida
34239
n/a

Geolocation is 41.8816606, -87.6926257

Rush University Medical Center
Chicago
Illinois
60612
n/a

Geolocation is 39.8264081, -89.6157473

Southern Illinois University School of Medicine
Springfield
Illinois
62702
n/a

Geolocation is 32.4980066, -93.768906

Biomedical Research Foundation
Shreveport
Louisiana
71103
n/a

Geolocation is 36.0563775, -115.2659777

Las Vegas Radiology
Las Vegas
Nevada
89113
n/a

Geolocation is 40.8476284, -73.8360251

Albert Einstein College of Medicine
Bronx
New York
10461
n/a

Geolocation is 35.9515785, -79.0145954

The University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27559
n/a

Geolocation is 36.0906568, -80.2715385

Wake Forest Baptist Health-Gerontology
Winston-Salem
North Carolina
27157
n/a

Geolocation is 39.6400784, -84.1751648

Valley Medical Center
Centerville
Ohio
45459
n/a
Lead Sponsor: 
Agency
Navidea Biopharmaceuticals
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Cornelia Reininger, MD, PhD
Study Director
Navidea Biopharmaceuticals
Study Contact: 
NamePhoneEmail
Joanna Shuping
614-822-2388
Locations
 
 
ClinicalTrials.gov ID 
NCT01886820 (follow link to view full record on ct.gov in new window)
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 Start Date: 
June 2013
Study End Date: 
December 2016
Enrollment: 
290