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[18F]NAV4694 for 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

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 minutes post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 minutes post injection for reporting.

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 more

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
1,793 Total Patients Enrolled
Cornelia Reininger, M.D., PhDStudy DirectorNavidea Biopharmaceuticals
~5 spots leftby Sep 2025
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