NAV4694 for Alzheimer's Disease
(APEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather information on memory, thinking, and blood markers in individuals who did not qualify for a previous Alzheimer's study. Researchers divide participants into three groups based on past screening results: some have positive blood tests but negative brain scans, while others have negative results for both. The study seeks to understand differences in cognitive changes across these groups, focusing on the roles of race, gender, and genetic factors. Individuals who didn't qualify for the AHEAD study due to their screening results may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to understanding Alzheimer's in diverse populations.
Will I have to stop taking my current medications?
Yes, if you are currently taking an FDA-approved medication for Alzheimer's disease, you will need to stop taking it to participate in this trial.
What prior data suggests that NAV4694 is safe for use in amyloid PET imaging?
Research has shown that [18F]NAV4694 is generally safe for use in PET scans, which help doctors visualize amyloid plaques in the brain. Studies have found that most patients tolerate this imaging agent well, with no major reports of serious side effects linked to its use.
The U.S. FDA and other global health agencies have approved several fluorine-18 agents, including [18F]NAV4694, for clinical use. This approval reflects a strong understanding of its safety. While no treatment is completely without risk, the available data on [18F]NAV4694 suggests it is safe for use in humans as an imaging agent.12345Why are researchers excited about this trial?
Researchers are excited about the Alzheimer's Plasma Extension trial because it explores innovative ways to diagnose Alzheimer's disease earlier and more accurately. Unlike traditional methods that primarily rely on symptomatic assessment, this trial focuses on detecting amyloid plaques through plasma biomarkers and PET imaging techniques. By distinguishing individuals based on plasma positivity or negativity and utilizing advanced imaging agents like NAV4694, the trial aims to refine diagnostic protocols, potentially leading to earlier intervention and improved outcomes for those at risk of Alzheimer's.
What evidence suggests that this trial's methods could be effective for Alzheimer's Disease?
Research has shown that NAV4694 is a promising tool for imaging amyloid plaques in the brain, which are linked to Alzheimer's disease. Studies have found that NAV4694 provides clear images of these plaques, similar to another commonly used tracer, PiB. NAV4694 attaches slightly better to amyloid and delivers more consistent results. This reliability makes NAV4694 a strong option for accurately tracking disease progression. While it doesn’t treat Alzheimer's directly, it aids in understanding the disease's progression, which is crucial for developing future treatments. Participants in this trial will be divided into different groups to evaluate NAV4694's effectiveness in imaging amyloid plaques.26789
Who Is on the Research Team?
Paul Aisen, MD
Principal Investigator
University of Southern California (USC) Alzheimer's Therapeutic Research Institute (ATRI)
Reisa Sperling, MD
Principal Investigator
Brigham and Women's Hospital and Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Collection of baseline cognitive and functional assessments and blood-based biomarker data
Longitudinal Follow-up
Participants undergo longitudinal follow-up of plasma biomarkers and cognitive and functional assessments
Follow-up
Participants are monitored for safety and effectiveness after the main observational period
What Are the Treatments Tested in This Trial?
Interventions
- NAV4694
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Approximately 250 participants who screen failed prior to PET imaging will undergo amyloid PET imaging with NAV4694 injection.
Approximately 250 participants who screen failed from the AHEAD study that were plasma negative / PET negative
Approximately 500 participants who screen failed from the AHEAD study that were plasma positive / PET negative
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Alzheimer's Clinical Trials Consortium (ACTC)
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
Alzheimer's Association
Collaborator
Citations
Autoradiographic comparison between [11C]PiB and [18F ...
Amyloid-β imaging through positron emission tomography (PET) has significantly transformed Alzheimer's disease (AD) research.
Standardized Expression of 18F-NAV4694 and 11C-PiB β ...
The standard centiloid method also showed that 18F-NAV4694 has slightly higher Aβ binding and lower variance than 11C-PiB, important properties ...
Clinical Trial Protocol: NAV4-04
Beta-Amyloid Imaging With [18F]NAV4694 Positron. Emission Tomography (PET) in Predicting Progression to. Alzheimer's Disease (AD) in Subjects with Mild ...
4.
researchgate.net
researchgate.net/publication/295503839_Standardized_Expression_of_18F-NAV4694_and_11C-PiB_beta-Amyloid_PET_Results_with_the_Centiloid_Scale(PDF) Standardized Expression of 18F-NAV4694 and 11C ...
The standard Centiloid method also showed that NAV4694 has slightly higher Aβ binding and lower variance than PiB, important properties for ...
Results of NAV4694 Amyloid Imaging Agent Clinical Trial ...
Results demonstrated that NAV4694 displayed imaging characteristics nearly identical to those of PiB and the authors believe these results show ...
Beta-Amyloid Imaging With [18F]NAV4694 PET in ...
To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment ( ...
Updated Appropriate Use Criteria for Amyloid and Tau PET
Three fluorine-18 Aβ agents are approved by the U.S. FDA, European Medicines Agency, and other global regulatory agencies for clinical use “to ...
8.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-of-the-pet-imaging-agent-18f-nav4694-in-subjects-with-probable-alzheimers-diseEfficacy and Safety of the PET Imaging Agent [18F]NAV4694 ...
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 ...
Amyloid beta plaque accumulation with longitudinal [18F ...
Introduction. [18F]AZD4694 is an amyloid beta (Aβ) imaging agent used in several observational studies and clinical trials.
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