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[18F]NAV4694 for Mild Cognitive Impairment (NAV4-04 Trial)

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 3 years
Awards & highlights

NAV4-04 Trial Summary

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.

Eligible Conditions
  • Mild Cognitive Impairment

NAV4-04 Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alzheimer's Disease
Secondary outcome measures
Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline
Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline
Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline
+6 more

NAV4-04 Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]NAV4694Experimental Treatment1 Intervention
Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months

Find a Location

Who is running the clinical trial?

Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,788 Total Patients Enrolled
Cornelia Reininger, MD, PhDStudy DirectorNavidea Biopharmaceuticals Inc.

Frequently Asked Questions

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~10 spots leftby Apr 2025