The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.
Re:Cognition Health is delivering an international clinical trial to evaluate whether a finger-prick blood test can improve how Alzheimer’s disease is diagnosed. Compared with current invasive and expensive diagnostic methods, this approach aims to provide a scalable solution for an earlier, more accurate, and affordable diagnostic method.
The clinical trial will enroll approximately 1,000 participants across the United Kingdom, the United States (US), and Canada. Participants in the trial include cognitively normal individuals, those with mild cognitive impairment, and those with mild to moderate Alzheimer’s disease. The trial also prioritizes inclusivity, with at least 25% of participants recruited from underrepresented communities to address historical gaps in research.
Comparing Biomarkers to Traditional Diagnostics
Researchers will analyze the blood samples for three key proteins associated with Alzheimer’s disease. The results will be compared against traditional diagnostic methods, including amyloid positron emission tomography (PET) scans, magnetic resonance imaging (MRI), and traditional speech and cognitive assessments.
“Delivering this study underscores our commitment to advancing earlier and more precise diagnosis,” says Emer MacSweeney, consultant neuroradiologist and CEO of Re:Cognition Health, in a release. “Biomarkers are transforming how we identify and treat Alzheimer’s disease, and this research moves us closer to a future where early intervention is the normal practice, and not the exception.”
Historically, clinicians have relied on costly brain imaging, invasive lumbar punctures, or the emergence of clinical symptoms, which often appear after the disease has significantly progressed. Blood-based biomarker testing could be used before symptoms arise to identify individuals at risk, enabling preventive strategies and earlier intervention in primary and secondary care settings.
Impact on Amyloid-Targeting Therapies
The identification of biological processes before symptoms become disabling is essential for the effective use of new treatments.
“Biomarkers allow clinicians to identify the biological processes of Alzheimer’s disease well before symptoms become disabling,” says MacSweeney in a release. “This is critical, as amyloid-targeting therapies such as Kisunla and Leqembi are most effective—and currently only available—when cognitive symptoms are still mild.”
The study is led by the Global Alzheimer’s Platform Foundation, with funding from LifeArc and support from the UK Dementia Research Institute. Re:Cognition Health has experience in biomarker-led clinical trials and has administered more than 12,500 doses of amyloid-targeting therapies across the US and the United Kingdom.
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