Collaborative effort to conduct a study aimed at improving the diagnosis of Alzheimer’s and related dementias for everyone

Washington D.C., Oct. 28, 2024 (GLOBE NEWSWIRE) — The Global Alzheimer’s Platform Foundation® (GAP) is pleased to welcome the initial strategic partners in the Bio-Hermes-002 study. These collaborations will enhance the unique, observational platform study that compares blood-based and digital biomarkers across a broad range of races and ethnicities that may help predict, diagnose, and detect Alzheimer’s disease.   

This partnership will build upon the findings from Bio-Hermes-001, expanding the evaluation of the ability of each biomarker, or combination of biomarkers, to predict the accumulation of amyloid and tau in the brain – hallmark characteristics of Alzheimer’s.   

Like Bio-Hermes-001, the Bio-Hermes-002 study is setting a standard for improving participation from people who are traditionally underrepresented in Alzheimer’s clinical research, with an unprecedented commitment to remain open until at least 25% of participants are from these communities. 

“We are pleased to bring together a distinguished consortium of leaders in research and technology to join us in the Bio-Hermes-002 study. This study is critical for the eventual development of tests that could be offered in a primary care setting, leveling the diagnostic and treatment playing field for many who for too long have lacked access to both,” said John Dwyer, President of GAP. “We will improve the lives of people living with and impacted by Alzheimer’s with this collaboration, and our partners in this study join us in our commitment to health equity through trial and participant diversity.”

Data from the test results from the Bio-Hermes-002 study will be securely stored on the AD Workbench from the Alzheimer’s Disease Data Initiative. The AD Workbench is a global, secure, cloud-based data sharing and analytics environment that enables researchers to share, access and analyze data across multiple platforms. After the study is closed, the data from Bio-Hermes-002 will eventually become available to Alzheimer’s researchers worldwide as part of the Alzheimer’s Disease Discovery Initiative’s AD Workbench.

New study partners will join current BioHermes-002 participant Biogen, which is providing working capital to support this phase of the study and who was previously a participant in Bio-Hermes-001. The exceptional partners providing blood-based biomarker assessments or digital assessments for this study are growing, but to date, include:

Cognivue’s FDA-cleared digital cognitive assessment technology will be part of the testing battery used in the Bio-Hermes-002 study. The study will utilize the Cognivue Clarity® device, a computerized cognitive assessment customized to each patient’s ability, providing a sensitive, reliable, and standardized approach to testing. The technology captures over 130,000 data points and the test adjusts in real-time as the participant answers questions.  

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics testing, working to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. In this study, they will be providing a panel of plasma-based biomarkers for fully automated testing for the hallmark proteins that may indicate Alzheimer’s.  Getting this confirmation earlier in the disease can improve lives for people with Alzheimer’s disease.

LifeArc is a UK-based self-funded medical research charity expert in taking promising scientific breakthroughs and turning them into new tests, treatments and devices for patients that need them most. LifeArc is supporting the validation of a finger-prick blood test detecting a panel of neurodegeneration biomarkers using cutting-edge and easy to use plasma separation devices provided by Capitainer. Such a unique test could simplify Alzheimer’s disease diagnosis as it does not require invasive imaging, while also broadening access, as the test does not require specialized testing locations and can be performed during a regular clinic visit.    

Linus Health, focused on transforming brain health for people across the world, will provide digital cognitive testing that also analyzes motor functions and speech for Bio-Hermes-002. Linus Health’s end-to-end brain health platform delivers a proven, practical and easily accessible means of enabling early detection, empowers providers with actionable clinical insights, and supports individuals and their caregivers with personalized brain health action plans.

Lucent Diagnostics, a Quanterix brand, will be utilizing Quanterix’s proprietary digital Simoa^TM technology. This multiplex technology has up to 1000x greater sensitivity than traditional automated immunoassay analyzers, revolutionizing precision health. Lucent Diagnostics will analyze and report out on several blood-based biomarkers on all Bio-Hermes-002 participants.

Retispec is a Toronto-based medical AI company that aims to enable widespread early and accurate detection of neurodegenerative disease markers through a simple eye exam. RetiSpec’s AI driven, non-invasive eye test will be evaluated in Bio-Hermes-002 where it investigates the real-time prediction of amyloid burden to aid in the evaluation of individuals for Alzheimer’s disease.

Sunbird Bio, is developing blood-based diagnostic tests that provide unprecedented insights to enable earlier, more accurate diagnosis and treatment of Alzheimer’s disease, Parkinson’s disease and other neurological disorders. For Bio-Hermes-002, they will test and analyze proteins that look to simplify the diagnosis for Alzheimer’s disease.

ViewMind has developed advanced technology for analyzing brain health functionally with sensitivity to correlate with structural brain changes. The solution is software as a medical device (SaMD) and is based on visual stimuli presented in a head-mounted display, and eye movement using advanced machine learning algorithms. An assessment battery takes about 15-minutes to perform.

The following companies are participating as a result of winning a competition, funded by Innovate UK, the UK’s innovation agency that supports organizations committed to improving dementia research using blood-based and digital biomarkers.  

AINOSTICS is using their technology to automatically and intelligently analyze scans to provide sensitive macro and micro-structural biomarkers of neurological conditions such as Alzheimer’s disease, which can be used to accurately diagnose and even predict future disease risk.  

Cambridge Cognition Limited  is providing tools to measure digital biomarkers through touch screen and voice assessments on an iPad. These tests look at memory, speech, and other cognitive skills that are affected early on in Alzheimer’s. Cambridge Cognition has extensive experience working with clinical trials and has supported over 3,000 studies.

iLoF  is a deep tech, digital health company pioneering the use if AI in personalized medicine, ingesting massive amounts of data to build a comprehensive digital library of biomarkers and biological profiles. iLoF’s contribution to this groundbreaking study centers on their AI-powered technology that combines photonics and multimodal data analysis. This innovative approach generates biomarkers through a non-invasive, scalable, and streamlined process, leveraging massive amounts of data to provide rigorous and tailored information to enhance patient stratification, reduce screen failures and improve the efficiency of Alzheimer’s research.

Cumulus Neuroscience Limited enables collection of longitudinal, objective real-world data, both in the clinic and in the home, for biopharma clinical trials. Cumulus’ NeuLogiq® platform includes an FDA 510(k) cleared dry-sensor EEG headset, a mobile tablet with repeatable, user-friendly versions of validated assessments, and a cloud infrastructure for data storage, AI-enabled automated processing and visualization.

For more information about the Bio-Hermes-002 study and how to participate, visit https://globalalzplatform.org/.

     
For immediate release:   
Contact: [email protected]   
  

About the Global Alzheimer’s Platform Foundation (GAP):
The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical research, as well as lowering the cost and duration of clinical trials to ensure that no one is left behind. As part of its mission, GAP supports more than 100 clinical research sites worldwide through study start-up and recruitment activities, promoting diversity in research studies, and giving attention to the citizen scientists who make research possible.

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