PHOENIX — Exosome Sciences, Inc., a diagnostic subsidiary of Aethlon Medical, Inc. (Nasdaq: AEMD), has announced the initiation of an Institutional Review Board (IRB) approved protocol for a research study involving retired NFL players and a data-supported biomarker candidate to potentially detect and monitor Chronic Traumatic Encephalopathy (CTE) in living individuals. The sample collection will be conducted in collaboration with Kendall Van Keuren-Jensen, Ph.D., co-director of the Translational Genomics Research Institute’s (TGen) Center for Noninvasive Diagnostics, for biomarker discovery projects.
With the approval of the protocol, investigators plan to initiate screening of candidate participants in the coming weeks. The study will enroll former NFL players, who are at high-risk of suffering from CTE, and control subjects who didn’t participate in activities that involved repetitive head trauma.
“The objective of our Exosome Sciences subsidiary is to further reinforce the clinical observations that resulted from our first study in former NFL players and then translate these outcomes into functional products that help those at risk of suffering from CTE and potentially other neurological disorders that involve the abnormal aggregation of Tau protein in the brain,” stated Aethlon Medical CEO, Jim Joyce.
To support the study enrollment, Exosome Sciences also announced the development of a “Players’ Council”, which will be led by former Cincinnati Bengal and NFL broadcaster, Solomon Wilcots.
“Members of the Players’ Council will provide input on how best to engage with former NFL players, as well as serve as local advocates for the study. In addition, these members have volunteered to share and distribute educational information through their social platforms. We believe this is the first step in tackling brain health issues for all athletes,” said Wilcots.
To date, the Council has established local ambassadors in the following locations:
- Steve Jordan, former Minnesota Viking
- Jamir Miller, former Arizona Cardinal, and Cleveland Brown
- John Bock, former Miami Dolphin
- Shawn Wooden, former Miami Dolphin
- Ron Pitts, former Buffalo Bill, and Green Bay Packer
- Nick Hardwick, former San Diego Charger
- Lee Rouson, former New York Giant
If fully enrolled, the study would be the largest to date involving former NFL players, who are at a high risk of suffering from CTE. The goal of the study for Exosome Sciences will be to further validate a CTE biomarker candidate known as plasma exosomal tau or a TauSome™. The biomarker was previously studied as part of the first NIH-funded CTE research program (The DETECT Study), which was managed by the Boston University (BU) CTE Center. In addition to evaluating TauSome™ levels in blood plasma, the study will evaluate the potential presence of the TauSome™ biomarker in the urine and plasma. Additionally, the TGen research team will analyze collected samples for potential extracellular RNA markers.
“Since our announcement of plans for the study earlier this year, we have received an overwhelming response from former NFL players and their family members. Researchers at TGen will use these samples to study extracellular RNAs, which may be useful for monitoring the central nervous system,” said Dr. Van Keuren-Jensen.
In a previous study known as DETECT, researchers examined 78 former NFL players and a control group of 16 former non-contact sport athletes. The study showed that plasma TauSome levels were significantly elevated in the NFL group as compared to the control group and that, within the former NFL player group, TauSome plasma levels correlated with performance on standardized tests of memory and psychomotor speed; the higher the TauSome level, the worse the performance. These results were subsequently published in the Journal of Alzheimer’s Disease. Access to the online version of the publication is available at http://tinyurl.com/zvyd23h. Based on these preliminary findings, the authors concluded that TauSome levels in blood plasma may be an accurate, noninvasive CTE biomarker. Since the publication, an ongoing analysis of the study data revealed that TauSome levels were approximately 9x higher on average in the NFL group as compared to control subjects.
In addition to studying the biomarker in CTE, Exosome Sciences plans to investigate the potential for TauSome plasma levels to serve as a candidate biomarker to monitor Alzheimer’s disease and other neurological tauopathies, which are disease conditions that involve the abnormal aggregation of tau protein in the brain.
To learn more about study dates and locations, please contact: CTE@tgen.org or visit tgen.org/CTE. The first collection date is scheduled for Wednesday, March 28, from 8:00 a.m. to 4:00 p.m. in Phoenix.