Enrollment Complete for Clinical Trial of LymPro, an Alzheimer’s Investigational Blood Diagnostic Test

Enrollment Complete for Clinical Trial of LymPro, an Alzheimer’s Investigational Blood Diagnostic Test
The second part of a clinical study evaluating the use of a blood diagnostic test for Alzheimer's disease — called the Lymphocyte Proliferation Test (LymPro Test) — is now fully enrolled, the trial's sponsor, Breakthrough Diagnostics, announced. The trial is ongoing at Leipzig University in Germany, and top-line results are expected in the first quarter of 2020. LymPro measures markers of immune cells present in the blood as a surrogate for loss of nerve cell function and the toxic accumulation of beta-amyloid plaques in the brain, which is a hallmark of Alzheimer's disease. Beta-amyloid, or just amyloid, is one of the prime suspects behind Alzheimer's. The accumulation of amyloid in plaques damages brain nerve cells (neurons), disrupting their communication and eventually causing their death. Some researchers believe that defects in the processes directing the production, accumulation or disposal of beta-amyloid are the primary cause of Alzheimer’s, a theory called “the amyloid hypothesis.” Neuronal damage and death also are thought to result from cellular abnormalities that lead to the reactivation of neurons' ability to proliferate, something considered aberrant for these cells that normally do not replicate. LymPro exploits the fact that such abnormalities in replication (or the cell cycle) seem to extend to immune cells in the blood. The test specifically measures the alterations in cell cycle activity in blood lymphocytes (a type of immune cell) as a biomarker of neuronal damage, for the early identification and screening of Alzheimer's. Breakthrough Diagnostics, a joint venture of Todos Medical and Amarantus, completed a first clinical study called LymPro PET 1 in 2018. It enrolled 20 Alzheimer's patients with mild cognitive imp
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