Cytox Ltd, (Cytox) a leading developer of assays for risk assessment and prediction of dementia, announced the start of two landmark exploratory clinical trials designed to evaluate a new blood assay platform that could potentially assist in the evaluation of an individual’s risk for dementia and Alzheimer’s.
The two studies will obtain samples from patients in Europe and in the United States. One study will identify mTOR dysregulation in well-characterized patients who are either cognitively normal or who have been diagnosed with probable Alzheimer’s disease, Fronto-temporal Lobe Dementia (FTLD) or Dementia with Lewy bodies (DLB).
The other study will evaluate the performance of the assay platform in patients with mild cognitive impairment assessing the relationship between the assay output (mTOR dysregulation) and the presence or absence, using Positron Emission Tomography (PET) imaging, of amyloid plaques in the brain, a hallmark pathology of Alzheimer’s disease. First results are expected toward the end of this year.
Blood samples from up to 370 patients
Blood samples from up to 370 patients will be obtained in clinical centers of excellence across the European Union and in the United States and sent for analysis by Cytox’s laboratory in Manchester, UK. Samples in the United States are being collected in a recently established partnership between Cytox and Selah Genomics of Greenville, South Carolina.
Commenting on the start of the clinical programme, one of the study investigators, Professor Bruno Dubois of the Neurological Institute of the Salpétrière University Hospital in Paris, France, said that, “While we are making real progress in identifying biomarkers of established disease, there is still a need for the earliest possible signal that dementia is a risk in individual patients. If we see a relationship between assessment of the mTOR pathway and clinical outcome with this assay platform, such information could help research and eventually better patient management.”
Advantages of blood-based biomarkers of Alzheimer's disease
Professor Harald Hampel, Excellence Chair and another of the investigators at Pierre and Marie Curie University (Sorbonne), Paris, further commented, “To find effective solutions to prevent the growing global Alzheimer epidemic we need to develop supportive biological markers of the disease. Finding suitable blood-based biomarkers would be most appealing since they are non-invasive, clinically generalizable across all healthcare sectors and can benefit patients across all regions in the world."
Dr Richard Pither, CEO of Cytox, said, “This is an innovative clinical program for a novel potential risk marker of dementia. The science behind mTOR’s role in the pathogenesis of Alzheimer’s and other dementias is extensive and from this science, our assay platform can potentially yield important practical clinical applications to help the fight against this significant public health problem.”
Dr Pither explains further that, “These milestones have enabled our own research as well as opening up potential future collaborations with academic research and the Pharmaceutical industry. In partnership with research into other biomarkers and new drug approaches, we hope to play a significant role in tackling the scourge of dementias such as Alzheimer’s disease.”
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