ToxGenSolutions (TGS) identified peripheral microRNAs with a potential to identify individuals at increased risk of developing Alzheimer’s disease (AD) before significant brain damage occurred and cognitive impairment becomes obvious. These microRNAs represent key events downstream of memory loss (the adverse outcome) as well as Alzheimer's relevant key events affected by neurotoxicants.

A pilot study has identified 8 microRNAs that, in combination, can identify individuals at risk for acquiring late-onset Alzheimer's disease at least 5 years before pathologic amyloid-beta and/or tau can be detected and clinical symptoms appear and can be diagnosed by the current diagnostic approaches. The accuracy of the microRNA profile is 98% (sens.: 100%; spec.: 92%) when evaluated in a small pilot study. Currently, 50 to 60% of the individuals diagnosed with mild cognitive impairment never develop pathology.

When validated, the microRNA profile will be incorporated in a microsensor-based diagnostic device that can provide an answer within 3 hours (as compared to months to even years when using the current approaches) and a a lower price since it would avoid the very expensive PET scans.

A full validation study has been set up, covering 1,050 patients, including patients with other forms of dementia. This application has to be seen as an effort to strengthen this effort by expanding the number of individuals enrolled in this validation exercise to 1,200.