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 behaviour are all characteristic symptoms of this disease. The progress of the disease 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.
More than 35 million people worldwide have AD or other types of dementia. Barring a significant medical breakthrough, predictions are that cases of dementia will nearly double every 20 years. There is currently no cure for AD. A more specific assay could 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.
Amorfix has applied its Epitope Protection™ and AMFIA™ technologies to develop the EP-AD CSF Diagnostic Test, an assay for the detection of the aggregated form of Aβ in human cerebrospinal fluid (CSF). These aggregates are not only found in the CSF of late-stage AD but also in patients with early-stage AD or mild cognitive impairment (MCI). Amorfix studies suggest that the EP-AD test is better at identifying patients with MCI than conventional spinal fluid testing.
Figure 1. The EP-AD test shows statistically significant differences in the levels of aggregated Aβ between clinical CSF samples from normal subjects and both MCI and AD patients.
Figure 2. Sensitivity of biomarkers for the detection of AD and MCI at 80% specificity.
Amorfix also has developed an ultra-sensitive assay for detecting aggregated Aβ in animal models of AD. The A4 (Amorfix Aggregated Aβ Assay), utilizes a specific process that enriches aggregated Aβ from brain, CSF or plasma, followed with detection by its AMFIA™ technology. The assay has a limit of detection at least 10-fold greater than other commercially available assays. The A4 can be used by researchers to identify potential lead compounds in animal models of AD. For more information on the A4: Visit our A4 webpage