The goal of this grant proposal is to validate a highly sensitive and specific diagnostic for Alzheimer’s disease (AD) and other dementias associated with misfolded protein aggregates in preparation for a commercial launch. AD is a progressive neurodegenerative disorder characterized by cognitive and memory defects and progressive impairment of daily activities. Current estimates suggest that approximately 5% of the population aged 65 and over, and approximately 20% of the population aged 80 years and over are affected by the disease. It is also estimated that worldwide more than 115 million people will be affected by dementia by 2050, the majority of whom will be AD. AD is one of a number of diseases associated with misfolding, aggregation and tissue accumulation of proteins. In addition to AD, these diseases, termed protein misfolding disorders (PMDs), include Parkinson’s disease (PD), Huntington’s disease, amyotrophic lateral sclerosis, systemic amyloidosis, prion diseases, and more. 

Despite this staggering disease burden, and despite the fact that the biotechnology and pharmaceutical industry have invested significant resources in developing novel treatments for AD, the field is littered with late-stage clinical failures, and so far disease-modifying treatments remain elusive. 

The value of our technology platform lies in our ability to detect soluble protein aggregates directly with high sensitivity and selectivity. This offers the opportunity to develop a sensitive diagnostic for AD that is suitable for routine clinical screening. Our technology platform detects what is widely believed to be the critical molecular pathogenic event directly and we therefore believe that our technology offers the best opportunity to develop a diagnostic test that is able to diagnose the disease prior to the onset of significant cognitive symptoms. 

The FDA has granted Amprion breakthrough-device status for PMCA-based detection of soluble misfolded αS aggregates in May 2019.