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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
[18F]NAV4694 PET visual assessment by centralized readers
Secondary outcome measures
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
1,838 Total Patients Enrolled
Cornelia Reininger, M.D., PhDStudy DirectorNavidea Biopharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of the PET Imaging Agent [18F]NAV4694 in Subjects With Probable Alzheimer's Disease
2012. "Efficacy and Safety of the PET Imaging Agent [18F]NAV4694 in Subjects With Probable Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01680588.
All > Aging
~6 spots leftby Apr 2025
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