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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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 moreNAV4-04 Trial Design
1Treatment groups
Experimental Treatment
Group I: [18F]NAV4694Experimental Treatment1 Intervention
Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months
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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.
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