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[18F]NAV4694 for Dementia

Phase 3
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 6 months
Awards & highlights

Study Summary

To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

Eligible Conditions
  • Dementia
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
Secondary outcome measures
Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Incidence of adverse events
Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]NAV4694Experimental Treatment1 Intervention
Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once

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Who is running the clinical trial?

Navidea BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,618 Total Patients Enrolled
Cornelia Reininger, MD 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
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
2013. "A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01886820.
All > Pathology
~24 spots leftby May 2025
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