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Efficacy and Safety of the PET Imaging Agent [18F]NAV4694 in Subjects With Probable Alzheimer's Disease
Phase 2
Waitlist Available
Research Sponsored by Navidea Biopharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 minutes post injection
Awards & highlights
No Placebo-Only Group
Summary
This is a phase 2, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of \[18F\]NAV4694 PET imaging in detecting beta-amyloid plaque in the brain in subjects with probable AD compared with healthy volunteers.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 minutes post injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 minutes post injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
[18F]NAV4694 PET visual assessment by centralized readers
Secondary study objectives
Assess changes in laboratory values after a single dose of [18F]NAV4694
Assess the incidence of adverse events after a single dose of [18F]NAV4694
Determine correlation of neuro-psychiatric tests with [18F]NAV4694 imaging
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: [18F]NAV4694Experimental Treatment1 Intervention
Single intravenous injection of 8.1 millicuries of \[18F\]NAV4694
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Who is running the clinical trial?
Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,466 Total Patients Enrolled
Cornelia Reininger, M.D., PhDStudy DirectorNavidea Biopharmaceuticals