The symptoms of Alzheimer’s disease can take between 15 and 20 years to manifest, but now this type of dementia could be diagnosed up to 17 years before the first clinical symptoms appear with an immuno-infrared sensor capable of detecting misfolding of the beta-amyloid protein, which characterizes Alzheimer’s, since as the disease progresses this abnormal folding generates the accumulation of deposits in the brain, the so-called plaques.
The device has been developed by scientists at the Center for Protein Diagnostics (PRODI) at Ruhr-Universität Bochum (Germany). Our goal is to determine the risk of developing Alzheimer’s dementia at a later stage with a simple blood test, even before toxic plaques form in the brain, to ensure that therapy can be started in time. Professor Klaus Gerwert, founding director of the Center for Protein Diagnostics (PRODI) at Ruhr-Universität Bochum.
The team conducted the study in cooperation with a group from the German Cancer Research Center in Heidelberg (DKFZ) led by Professor Hermann Brenner, and have published the results in Alzheimer’s & Dementia. The current research builds on a previous comparative study published in the same journal last March, in which the researchers used complementary monomolecule array (SIMOA) technology.
Screening for Alzheimer’s risk in asymptomatic people
Scientists analyzed the blood plasma of participants in the ESTHER study in Saarland to identify biomarkers of Alzheimer’s. The blood samples had been taken between 2000 and 2002 – when the participants were between 50 and 75 years old and had not yet been diagnosed with Alzheimer’s disease – and had been frozen.
“With the incorrect folding test we want to establish a precautionary measure for the elderly and determine their risk of developing Alzheimer’s”
To carry out the current study, 68 participants who had been diagnosed with Alzheimer’s during the 17-year follow-up period were selected, comparing them with 240 control individuals without this diagnosis. The goal of the team led by Klaus Gerwert and Hermann Brenner was to check whether signs of Alzheimer’s disease could be found in the blood samples at the start of the study.
The immuno-infrared sensor was able to identify the 68 test subjects who subsequently developed Alzheimer’s with a high degree of accuracy in the test. To make a comparison, the researchers tested other biomarkers with the complementary and highly sensitive SIMOA technology, specifically the P-tau181 biomarker, which is currently being proposed as a promising biomarker candidate in several studies.
“However, unlike the clinical phase, this marker is not suitable for the early, symptom-free phase of Alzheimer’s disease,” says Klaus Gerwert. “Surprisingly, we found that the concentration of glial fiber protein (GFAP) can indicate the disease up to 17 years before the clinical phase, although it does so with much less precision than the immuno-infrared sensor.” However, by combining the abnormal folding of beta-amyloid and the concentration of GFAP, they were able to further increase the accuracy of the test in the asymptomatic phase.
The Bochum researchers hope that an early diagnosis based on amyloid-beta misfolding will allow Alzheimer’s drugs to be administered so early that their effect is significantly enhanced; for example, the drug Aduhelm, which was recently approved in the United States.
“With the misfold test we want to establish a precautionary measure for the elderly and determine their risk of developing Alzheimer’s disease,” said Klaus Gerwert. “The vision of our newly founded betaSENSE is that disease can be stopped in a symptom-free state before irreversible damage occurs.” The sensor is still in the development phase, but has already been patented worldwide and BetaSENSE’s goal is to fully develop the Immuno-Infrared sensor and get it approved as a diagnostic device for use in clinical laboratories.
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