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New ‘smart patch’ could be used to detect Alzheimer’s

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A Swansea University scientist has developed a new ‘smart patch’ that can detect markers of neurodegenerative diseases, such as Parkinson’s and Alzheimer’s, through the use of microneedle technology.

This breakthrough in the advancement of transdermal capability would mean ‘smart patches’ could be used to detect certain biomarkers within skin interstitial fluid (ISF) in a ‘bloodless’ manner. 

These patches are comprised of arrays of tiny needles (microneedles) designed to break the skin barrier – in a minimally invasive manner – and monitor the biomarkers of clinical significance. They can be self-administered for point of care diagnosis at GP practices or even at home. This innovative research has the potential to change the landscape of early neurodegenerative disease detection.

Dr Sanjiv Sharma, who previously developed the world’s first COVID-19 ‘smart patch’, explained how the technology works: “The skin is the largest organ in the body – it contains more ISF than the total volume of blood.  This fluid is an ultrafiltrate of blood and holds biomarkers that complement other biofluids such as sweat, saliva, and urine. It can be sampled in a minimally invasive manner and used either for point of care testing or real time using microneedle devices.

“We employed microneedle array-based biosensing patches as wearable transdermal sensors to detect the proinflammatory cytokine IL-6.  IL-6 is present in the skin ISF with other cytokines and is implicated in many clinical states including neurodegenerative diseases and fatal pneumonia from SARSCoV 2. We have been able to detect IL-6 at concentrations as low as 1 pg/mL in synthetic skin ISF, indicating its utility for routine point of care, bloodless measurements in simpler settings, worldwide.

He added: “The devices we developed are scalable, and the resulting sensor has a short measurement time (6 minutes), with high accuracy and a low limit of detection.  This new diagnostic tool, for screening of inflammatory biomarkers in point of care testing, will see the skin act as a window to the body and vital organs such as the brain.”

The work was done in collaboration with Biomark, ISEP, Porto, Portugal. 

Co-author, Felismina Moreira from the School of Engineering, Polytechnic Institute, Portugal added: “Biomark ISEP Porto have pioneered applications of molecular imprinted polymers (MIPs) and extended them to different healthcare applications. Together with Swansea’s expertise in transdermal diagnostics we have demonstrated that the MIPs together with the microneedle arrays offers a fantastic platform for the development of point of care devices for bloodless testing. These can be extended to diagnostics for cardiovascular, cancer and neurodegenerative disorders.”

Swansea University is currently working with its research partners in the UK, Portugal, France and Japan towards furthering the field of transdermal diagnostics and extending it for the development of diagnostic devices for a plethora of healthcare applications.

 

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AI tool flags undiagnosed Alzheimer’s cases

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A new AI tool flags early Alzheimer’s, identifying about four in five people who would otherwise be missed by clinicians.

Trained on UCLA Health patient records and tuned to work more fairly across Black, Latino and Asian patients who are often underdiagnosed, the system aims to find people earlier, when treatment and lifestyle changes can still help.

In tests on more than 97,000 UCLA Health records, the model reached a sensitivity of about 77 to 81 per cent across non-Hispanic white, non-Hispanic African American, Hispanic/Latino and East Asian groups, roughly double that of conventional supervised models, the authors report.

UCLA Health researchers developed the tool and built fairness measures into training before checking the model’s picks against genetic benchmarks.

Patients flagged as likely cases but previously unlabelled showed higher polygenic risk scores and APOE ε4 counts than those the system did not flag.

Polygenic risk scores measure the combined effect of multiple genes on disease risk, while APOE ε4 is a genetic variant linked to increased Alzheimer’s risk.

The AI looks beyond memory-related billing or diagnostic codes and finds patterns that include signals such as decubitus ulcers, commonly known as pressure sores, and palpitations, which could prompt clinicians to take a closer look and consider screening.

“We were able to capture about 80 per cent of the people who actually would have undiagnosed Alzheimer’s disease,” said Dr Timothy Chang.

He said studies estimate up to 40 per cent of Alzheimer’s cases go undiagnosed, a gap that hits Black and Latino communities especially hard.

The framework learns from both labelled Alzheimer’s cases and unlabelled patient records, using race-specific probabilistic labelling and post-processing cutoffs tuned for group benefit equality to reduce bias.

Rather than relying only on diagnostic codes, the model draws on a wide range of electronic health record features, including diagnoses, encounter history and age, helping uncover likely cases that never received a formal label.

Earlier detection matters because disease-modifying treatments and targeted clinical referrals are now an option for people in the earliest symptomatic stages of Alzheimer’s.

Amyloid-targeting therapies such as lecanemab and donanemab are intended for early disease, which makes timely screening and specialist evaluation more consequential for patients and families.

Lifestyle changes and symptom management remain key tools for slowing decline, planning care and helping families prepare.

Researchers stress that the tool is a flagging system, not a diagnosis, and that its output should trigger follow-up evaluation rather than replace clinical judgement.

The team plans prospective validation in partner health systems to test how well the tool generalises and how useful it is in real-world practice before any routine roll-out.

Models can reveal new biases when used outside the environment where they were trained. Clinicians and ethicists will also have to weigh benefits against the risk of false positives, added patient anxiety and uneven access to specialist care.

The coming months will focus on broader testing and conversations with health systems about how to roll out the technology responsibly, if future studies support its use.

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Gap partners with Spear Bio on Bio-Hermes-002

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Gap is partnering with Spear Bio on Bio-Hermes-002, an Alzheimer’s study comparing blood and digital biomarkers across cognitive conditions.

The observational platform study compares blood-based and digital biomarkers (measurable signs in blood or behaviour) across a broad range of cognitive conditions, alongside MRI and PET brain scans and diverse racial and ethnic groups, to generate data that may help predict, detect and diagnose Alzheimer’s disease and related dementias.

The study gathers data on how each biomarker, or combinations of biomarkers, perform in assessing, diagnosing or predicting pathologies linked to Alzheimer’s and related dementias, including amyloid and tau in the brain.

Amyloid plaques and tau tangles are abnormal protein deposits and are hallmark features of Alzheimer’s disease.

John Dwyer, president of GAP, said: “We’re proud to have Spear Bio as a valued partner in the Bio-Hermes-002 study.

“Their technology platform is consistent with our goal to catalyse and scale early-stage disease diagnostics and monitoring, therby transforming how we treat patients and conduct clinical trials for Alzheimer’s and related dementias.

“By advancing biomarker detection, we hope to accelerate meaningful progress for individuals and families affected by these conditions.”

In Bio-Hermes-002, Spear Bio will provide results of blood-based biomarker analysis using its SPEAR UltraDetect assay platform, which the company says offers attomolar sensitivity from a one microlitre diluted sample, and what it describes as superior specificity in a homogenous wash-free format, aiming to change early-stage diagnostics and monitoring.

This builds on findings from Bio-Hermes-001.

Data from Bio-Hermes-002 will be stored on the AD Workbench from the Gates Ventures Alzheimer’s Disease Data Initiative (ADDI).

The AD Workbench is a global, secure, cloud-based data sharing and analytics environment that enables researchers worldwide to share, access and analyse data across multiple platforms.

Spear Bio joins industry partners in the study, including Biogen, Eli Lilly and Company, IXICO and Roche, along with a growing list of partners providing blood-based biomarker assessments or digital assessments for Bio-Hermes-002.

To date, the partners include AINOSTICS, Alamar Biosciences, Beckman Coulter Diagnostics, Cambridge Cognition Limited, Cognivue, Cumulus Neuroscience Limited, Fujirebio, iLoF, LifeArc, Linus Health, Lucent Diagnostics, a Quanterix brand, Sunbird Bio and ViewMind.

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Insilico in US$66m deal for Parkinson’s drug

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Insilico Medicine has agreed a US$66m deal with a Chinese biotech for half of the rights to a brain-penetrant Parkinson’s drug.

Under the agreement, the artificial intelligence-powered drug developer will take the lead on bringing the preclinical asset, dubbed ISM8969, into a phase 1 trial.

Hygtia Therapeutics will then take over for further studies and onward toward regulators and commercialisation.

Ren Feng is co-chief executive and chief scientific officer at Insilico.

Feng said: “Targeting neuroinflammation via NLRP3 represents a scientifically sound and high-potential approach to treating neurodegenerative and age-related diseases.

“However, developing a safe molecule with good blood-brain barrier penetration remains a formidable obstacle for drug developers.

“Through our generative AI platform, we have designed a molecule specifically engineered to overcome this barrier.

“We are pleased to partner with Hygtia Therapeutics.

“We believe that through our combined efforts, we can accelerate its clinical progress to address significant unmet medical needs.”

ISM8969 is an NLRP3 inhibitor.

NLRP3 is a protein involved in inflammation, and blocking it is being explored as a way to address a range of neuroinflammatory and cardiometabolic diseases. Interest in NLRP3 inhibition has increased in the past year.

Earlier this month, Eli Lilly paid US$1.2bn to acquire Ventyx Biosciences in the wake of a phase 2 study tying Ventyx’s lead NLRP3 inhibitor to improvements in Parkinson’s symptoms.

That same NLRP3 inhibitor had also been shown to cut levels of a biomarker for stroke and other serious risks by almost 80 per cent within a week in a separate mid-stage study.

Preclinical data for ISM8969 have “demonstrated the molecule’s robust efficacy, favourable safety profile and marked anti-inflammatory activity in various disease models,” said Insilico, which also noted the therapy’s “desirable blood-brain barrier penetration.”

The blood-brain barrier is the protective barrier around the brain that many drugs struggle to cross.

Insilico, which went public on the Hong Kong Stock Exchange last month, said it had discovered ISM8969 via its generative chemistry engine Chemistry42.

As well as an upfront fee of US$10m, Insilico is in line for up to US$56m in milestone payments from Hygtia.

Insilico has attracted interest from pharmaceutical companies for its AI-enabled drug discovery technology, including Sanofi, Pfizer, Menarini Group and Boehringer Ingelheim.

Most recently, Lilly agreed a deal worth more than US$100m in November.

Hygtia, which was founded last August after being incubated by Fosun Pharma, said the agreement with Insilico “marks a pivotal step in our global strategy.

This partnership aligns with our strategy to expand our innovative neuroscience pipeline through high-quality assets.”

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