Diagnostic Test for Alzheimer's Disease
Alzheimer's disease (AD) is the most common of all chronic neurodegenerative diseases. Memory loss along with a gradual decline of other intellectual abilities and changes in personality or behavior are all characteristic symptoms of this disease. The progress of the diseases can take from 5 to 20 years. While no one knows exactly what causes AD, it is associated with deposits of Aβ aggregates in the brain, known as amyloid. It is believed that Aβ aggregates result from abnormal production and accumulation of the Aβ peptide. The only definitive diagnostic for AD is post-mortem examination of brain tissue.
Early detection of neurodegenerative diseases has the potential to significantly change the prognosis and quality of life for patients by allowing earlier application of emerging therapies. More than 35 million people worldwide have Alzheimer's disease (AD) or other types of dementia. Barring a significant medical breakthrough, predictions are that cases of dementia will nearly double every 20 years. By 2050, it could affect more than 100 million people. Approximately 10% of people age 65 have AD, while 50% have the disease when they reach 85 years old. There is currently no cure for AD, but the development of specific and sensitive biomarker assays may provide a means to identify patients for earlier enrollment in clinical trials for emerging therapeutics.
Amorfix Life Sciences has developed the A4 (Amorfix Aggregated Aβ Assay), an ultra-sensitive postmortem brain assay, to address the need to improve current methods used for identification of potential lead compounds in preclinical trials. The A4 provides an immunochemical method for early detection of the aggregated amyloid-beta peptide, a recognized biomarker for AD, and quantitatively measures changes in aggregated Aβ following treatment with therapeutics without the need for immunohistochemistry. This assay eliminates the need for formic acid extraction, and detects the presence of aggregated Aβ in the brains from animal models of AD several months prior to detection with immunohistochemistry.
Amorfix has developed methods for the specific enrichment of the aggregated Aβ from brain, CSF or plasma, and an immunoassay to detect Aβ with a limit of detection at least 10-fold greater than other commercially available assays.
Building on the success of the A4 in detecting aggregated Aβ in transgenic AD models, Amorfix is working to increase the sensitivity and specificity of this assay in animal models, and applying this experience to the development of a human CSF or plasma assay. A blood test for AD would enable early diagnosis leading to improved patient outcomes, enhance disease monitoring and improve recruitment of clinically relevant patients into therapeutic clinical trials leading to improved assessments of new treatments.
For more information on the A4: Download our A4 presentation here.
