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 impairment and dementia and evaluated how well the LymPro test matched disease assessments by brain imaging using amyloid positron emission tomography (PET) scans — which visualize amyloid plaques in the brain -—and other Alzheimer’s biomarkers.

The trial’s results, announced in July, revealed a strong and significant correlation between LymPro and amyloid PET imaging scores, indicating that LymPro may hold promise as a diagnostic test for Alzheimer’s.

“While the pre-specified interim analysis findings are preliminary, these strong correlative LymPro Test results suggest an underlying association between cell cycle dysfunction (CCD) as measured in lymphocytes with the histological evidence of CCD occurring in the brains of Alzheimer’s patients,” Paula Trzepacz, MD, chief medical officer at Todos, said in a press release.  “This intermediary correlation … is encouraging, considering the documented neuropathological concurrence of CCD and β-amyloid pathology in AD patients. Given that previous research shows LymPro distinguishes healthy older controls from MCI and AD patients, and that this study population represents routine clinical practice, we are very excited by these findings,” she said.

To confirm those results, Breakthrough Diagnostics and its collaborators then decided to include an additional group of 20 participants in a second part of the trial, LymPro PET 2, which has now completed enrollment.

The data from both LymPro 1 and LymPro 2 are expected to be published together in a scientific journal in 2020.

“LymPro is a unique immune system-based Alzheimer’s blood test,” Herman Weiss, M.D., Todos’ president, and CEO said in a press release. “LymPro could prove to be a major breakthrough for  Alzheimer’s disease diagnosis by measuring cell cycle dysregulation and amyloid, together, conveniently as part of a blood workup in routine clinical practice,” he said.

The trial is led by Thomas Arendt, MD, professor at Leipzig University and director of the Paul Flechsig Institute of Brain Research. Arendt has 30 years of research experience in therapeutic and diagnostic strategies of neurodegenerative disorders, including Alzheimer’s. He is one of the researchers who pioneered the “cell-cycle theory” of Alzheimer’s disease, which was developed as a diagnostic and therapeutic concept.