Research Actitivy
Evanthea Trial
Our primary focus has been as a principal investigator in the IRB approved Evanthea Trial to understand the impact of precision medicine on outcomes in patients with mild cognitive impairment. We have been working with this Trial since 2023. We have also been working on precision medicine since 2018 and were a co-author on a paper in 2018 that described 100 cases of patients with cognitive decline that responded to precision medicine.
The study has 6 centers – Miami FL, Cleveland OH, Marin CA, Walnut Creek CA, Nashville TN and Sacramento CA. A total of 72 subjects have been enrolled in the study. Two thirds of the subjects are in group A, which receives precision medicine, 1/3 of the subjects are group B which receives usual standard care. The study lasts for 9 months after which subjects in group B have 6 months of precision medicine.
This is a very unique study that assesses an APPROACH of care –precision medicine –rather than a SINGLE intervention. All subjects get the same set of initial labs and outcome metrics. Investigators are allowed to use their judgment on what clinical interventions are allowed from a defined set of interventions. These interventions include lifestyle changes – food, sleep, exercise, brain exercises, stress reduction; supplement support to address root causes and provide neurological support, pharmaceuticals if indicated to address root causes, as well as neuromodulatory support to provide neurologic support. As a result, care is personalized and precise – driven by the patient’s individual biomarkers and needs.
The pilot study of precision medicine done in 2021 saw a highly clinically significant impact on cognitive outcomes ; 84% of the population improved the neurocognitive index on CNS Vital Signs , with an average improvement of 10 points on the standard score (15 points on the standard score is a full standard deviation of change).
All 13 of the actively enrolled group A and group B patients at Rezilir Health have received the initial 9 months of care as of August 2025 and we are busy analyzing our data. We expect the full study will be completed by October 2025 and that the pre-print for the study results will be published no later than early 2026. Dr. Dale Bredesen, the lead investigator, gave a recent talk at a CIRS conference where he discussed the progress of the study.
In the talk, he discussed that preliminary analysis revealed a large, clinically significant and statistically significant difference between the intervention group and standard of care group. He also shared data that showed that there were considerable differences in outcomes between the 6 centers. Dr. Bredesen’s hypothesis is that teamwork & execution matters in the implementation of precision medicine. The current Rezilir team on brain health (e.g., physician, nurse practitioner, nutritionist, health coach, neurofeedback tech, clinical assistant, hyperbaric tech) has been working together as a team for 5 plus years.
Rezilir Health is currently working on a separate methodology paper on our approach in the Evanthea Trial to implement neuromodulatory interventions with the assistance of multiple QEEGs. We will be doing this to help advance precision medicine as we were the only center in the Evanthea study where patients had access to hard chamber hyperbaric oxygen therapy, 19 channel neurofeedback, high intensity light therapy, low intensity photobiomodulation, and direct electrical stimulation therapies as part of precision medicine interventions. We anticipate this paper will be available in early 2026.
Case Study on Cortical Basal Degeneration
We have submitted a case study on a patient with cortical basal degeneration that responded very positively to precision medicine in collaboration with Dr. Dale Bredesen. We anticipate this study will be available in late 2025.
TB006
We are an approved investigator site to look at real world experience of TB006, a monoclonal antibody against galectin-3 for patients with mild cognitive impairment and dementia. TB-006 is currently approved by the FDA for compassionate use in patients with MCI and dementia who have not responded to other FDA approved therapies. All patients who receive TB-006 need to be enrolled in a safety monitoring program at an approved investigator site.
Brain Health Registry
Rezilir Foundation, Inc is sponsoring a Registry of multimodal care for patients with cognitive decline through the WCB Institutional Research Board (IRB tracking ID: 20191727). The goal of this registry is to gather real world outcomes of precision medicine on patients with cognitive decline ideally through multiple centers so that we can get answers quicker.
Long Covid Registry
We are participating in an IRB approved registry led by researchers at the Institute of Neuro Immune Medicine at Nova Southeastern to gather real world outcomes of precision medicine on patients with long Covid. Dr. Tanio is a clinical faculty member of the Institute and Rezilir Health is an active contributor of cases.
Timeline Highlights
2018: Precision-medicine program launched; co-authored 100-case paper.
2021: Pilot study shows robust signal on cognitive outcomes.
2023: Became a principal investigator site for the Evanthea Trial.
2024–2025: Enrollment and care delivery across six Evanthea centers; Rezilir completes initial 9-month phase for 13 participants (Aug 2025).
Late 2025: Cortical Basal Degeneration case study expected.
Oct 2025: Evanthea primary study completion (target).
Early 2026: Evanthea pre-print and neuromodulation methodology paper (targets).
IRB Note: IRB oversight includes WCB IRB for registry work (Tracking ID 20191727) and collaborating institutional IRBs where applicable. Timelines are prospective targets and may evolve based on data and peer review.
