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

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

Official Title
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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

Conditions
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Dementia, Alzheimer's Disease

Intervention / Treatment
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* Drug: [18F]NAV4694


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects will be at least 21 years of age. Subjects will have a life expectancy of approximately 6 months Subject health is adequate as determined by the investigator to receive [18F]NAV4694 Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of [18F]NAV4694 injection. Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour. Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved). Subjects have been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (LAR) (for individuals with dementia). Exclusion Criteria: Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18F]NAV4694 injection. Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs. Has any history of any transmissible spongiform encephalopathy (prion disease). Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration. Is allergic to the investigational product or any of its constituents.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]NAV4694<br>Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once | Drug: [18F]NAV4694<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology |  | 6 Months | 
| Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology |  | 6 Months | 
| Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology |  | 6 Months | 
| Incidence of adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer's Disease, Terminally Ill