Ciatrix Announces the REGLYDE Clinical Trial

An Investigational Study on Computerized Yoga Movement Technology for Alzheimer's Disease

Alzheimer's disease affects approximately 6.7 million Americans, with projections suggesting this number could reach nearly 13 million by 2050. As researchers continue seeking effective interventions, a revolutionary approach is emerging that harnesses the power of yoga-based movement to potentially slow cognitive decline.

Ciatrix is excited to announce the REGLYDE Clinical Trial, representing the world's first Phase II and III clinical trials investigating computerized yoga technology as a potential treatment for Alzheimer's disease.

This groundbreaking research initiative explores whether precisely guided, yoga-based movements can enhance the brain's natural cleaning system and potentially modify the course of this devastating condition. Unlike traditional pharmaceutical approaches, REGLYDE focuses on boosting the body's intrinsic mechanisms to promote brain health.

Understanding the Alzheimer's Treatment Challenge

Current Alzheimer's treatments primarily focus on managing symptoms rather than addressing underlying causes. FDA-approved medications can temporarily improve cognitive symptoms for some patients, but their effectiveness varies widely and diminishes over time, thus there are no effective treatment options for the disease. Additionally, many pharmaceutical interventions come with significant side effects that can impact quality of life.

The limitations of existing treatments have created urgent demand for alternative approaches that might modify disease progression. This gap in effective interventions has driven researchers to explore complementary pathways, including how movement therapies might influence brain health at a fundamental level.

The Need for Innovative Solutions

With over 55 million people worldwide living with dementia (Alzheimer's being the most common form), the societal and economic toll continues to grow. In the United States alone, the cost of caring for those with Alzheimer's and other dementias is estimated at $360 billion annually. These bleak statistics highlight the urgent need for innovative treatment approaches, serving as the central motivation behind the REGLYDE Clinical Trial.

The Science Behind REGLYDE: Harnessing the Glymphatic System

At the heart of the REGLYDE approach lies the glymphatic system—the brain's natural waste-clearing mechanism. This recently discovered "brain plumbing" uses cerebrospinal fluid (CSF) to flush out toxins and metabolic byproducts, including beta-amyloid and tau proteins associated with Alzheimer's disease.

The glymphatic system works most efficiently during deep sleep, when the brain's extracellular space expands by up to 60%, allowing greater CSF flow and more effective clearance of neurotoxins. Scientists at Ciatrix have identified a previously unexplored connection between natural spinal motion, respiration patterns, neurological function, and enhanced glymphatic clearance.

REGLYDE: REversing GLYmphatic DEmentia

The name REGLYDE itself—an acronym for Reversing Glymphatic Dementia—reflects the fundamental hypothesis driving this research: that enhancing cerebrospinal fluid circulation and production could support brain health and potentially slow, halt, or even reverse cognitive decline by improving the brain's natural cleaning processes.

Our research suggests that synchronizing specific spinal movements with controlled respiration may significantly boost cerebrospinal fluid circulation.

This enhancement could increase glymphatic system clearance by orders of magnitude—substantially exceeding the effects of any pharmacological intervention tested to date.

Yoga Movements and Brain Health: The Critical Connection

The link between movement and cognitive health has been studied for decades, but the REGLYDE approach targets a specific mechanism: how yoga-based movements can enhance CSF flow dynamics when properly synchronized with breathing.

Traditional yoga practices, particularly those involving pranayama (breath control) techniques, have long been associated with cognitive benefits.

The REGLYDE Clinical Trial builds upon this foundation by adding technological precision to these ancient practices.

Precision in Movement Therapy

Ciatrix researchers have discovered that certain movement patterns, when performed with precise timing relative to the respiratory cycle, can create pressure differentials that dramatically enhance CSF circulation throughout the brain and spinal column.

Studies on yoga interventions for cognitive health have shown promising results, with regular practitioners demonstrating better memory function, attention, and processing speed compared to non-practitioners. REGLYDE takes these findings further by focusing specifically on movements designed to maximize glymphatic clearance.

REGLYDE Clinical Trial Overview

The Phase II Clinical Trial will commence in Prague, Brno, and Bratislava.

The REGLYDE Clinical Trial consists of two phases launching in June in the Czech Republic and Slovakia. The Phase II study will involve 60 participants over a 4-week period, while the Phase III expansion will include 240 participants studied over 12 weeks.

Comprehensive Assessment Approach

The trials will evaluate multiple outcomes to determine the therapy's effectiveness:

• Brain toxin clearance measurements

• Biomarkers of neurodegeneration

• Sleep quality parameters

• Cognitive function assessments

This multi-faceted approach allows researchers to evaluate both objective biological changes and subjective improvements in participant functioning. The trial design meets rigorous scientific standards needed for potential FDA consideration if results prove promising.

Study Population

Participants include individuals diagnosed with mild to moderate Alzheimer's disease. The multi-center approach across different locations helps ensure diversity in the study population and strengthens the generalizability of any findings. This design follows established protocols for interventional studies while adapting to the unique characteristics of movement-based therapy.

Fluere™ Technology: Bringing Precision to Movement Therapy

Central to the REGLYDE Clinical Trial is the Fluere™ device—an investigational technology developed by Ciatrix for this research. This computerized neuro-therapy system synchronizes spinal movements with slow respiration to enhance cerebrospinal fluid circulation and improve glymphatic clearance.

Important note: Fluere™ is an investigational device not FDA-approved for Alzheimer's disease treatment.

Its efficacy is the primary question this clinical trial aims to answer.

The technology guides participants through precise movement sequences, ensuring optimal timing between spinal position changes and breath cycles. This technological guidance allows for consistency across participants and sessions, something difficult to achieve with traditional yoga instruction alone.

While the device plays an important role in the research, the therapeutic core remains the yoga-based movement practice itself and its potential impact on brain health. The technology simply ensures precision in delivery and measurement of outcomes.

Commonly Asked Questions About REGLYDE

How does yoga therapy help Alzheimer's patients?

Yoga therapy for Alzheimer's focuses on enhancing glymphatic clearance—the brain's natural waste-clearing process. By synchronizing specific spinal movements with breathing patterns, this approach may improve the circulation of cerebrospinal fluid, helping to flush out toxic proteins associated with Alzheimer's disease. According to a study, yoga moderately improves cognitive function, especially attention, processing speed, executive function, and memory, with acute sessions showing the strongest effects.

What distinguishes REGLYDE from traditional Alzheimer's treatments?

Unlike pharmaceutical approaches that target specific molecular pathways, REGLYDE aims to enhance the brain's intrinsic waste-clearance mechanisms. This non-pharmaceutical intervention works with the body's natural processes rather than introducing external compounds. The approach is designed to be non-invasive, and potentially address a fundamental aspect of brain health that current treatments don't target.

How is improvement measured during the trial?

The REGLYDE Clinical Trial uses multiple assessment methods, including standardized cognitive tests, biomarker analysis of blood and cerebrospinal fluid, advanced brain imaging and sleep quality assessment. This comprehensive approach measures both biological changes and functional improvements that matter to patients and caregivers.

The Collaborative Approach to Alzheimer's Research

The REGLYDE Clinical Trial is part of a broader collaborative effort to combat Alzheimer's disease.

Ciatrix is proud to participate in the Alzheimer's Moonshot, an initiative led by StartUp Health in partnership with the Alzheimer's Drug Discovery Foundation (ADDF) and Gates Ventures.

This collaboration brings together leading entrepreneurs, researchers, and funders to accelerate breakthroughs in Alzheimer's prevention, diagnosis, and care. By joining forces with these organizations, Ciatrix can leverage collective expertise and resources to more rapidly advance promising interventions.

The Power of Community in Medical Research

Medical breakthroughs rarely happen in isolation. The most significant advances typically result from collaboration across disciplines, institutions, and even countries.

The REGLYDE Clinical Trial exemplifies this approach, combining insights from neuroscience, yoga traditions, technology, and clinical medicine to explore a truly innovative intervention possibility.

Ciatrix is prepared to fund smaller clinical trials internally, beginning with the Phase II study across three clinical sites. However, to achieve scientifically significant results that meet FDA and other national health agency standards, the research team needs to expand the participant pool and replicate outcomes in multiple trial centers.

Democratizing Alzheimer's Research Through Crowdfunding

Rather than relying solely on traditional funding pathways, which can delay progress, Ciatrix will be launching an crowdfunding campaign to accelerate this innovative research. This approach democratizes the fight against Alzheimer's, allowing individuals concerned about this disease to directly contribute to potentially life-changing research. Our goal is clear to develop an effective, non-invasive disease-modifying therapy.

Contributions will support:

• Participant recruitment and monitoring

• Data collection and analysis

• Regulatory approvals and documentation

• Fluere™ device development and distribution

By contributing to this campaign, supporters become part of an effort that could potentially change how we approach Alzheimer's treatment.

The campaign will launch soon, with more details available on the Ciatrix website at https://www.ciatrix.com/reglyde.

The Future of Non-Pharmaceutical Interventions for Alzheimer's

The REGLYDE Clinical Trial represents a significant shift in Alzheimer's research—moving beyond the traditional pharmaceutical model to explore how we might enhance the body's intrinsic healing mechanisms.

The integration of ancient wisdom from yoga traditions with cutting-edge neuroscience is the kind of innovative thinking needed to address complex conditions like Alzheimer's disease. By exploring previously overlooked connections between movement, breathing, and brain health, REGLYDE opens new possibilities for Alzheimer's care.

As our understanding of the glymphatic system continues to evolve, interventions that enhance this natural waste-clearance mechanism may prove valuable not just for Alzheimer's but for a range of neurological conditions characterized by protein aggregation and impaired waste clearance.

Be Part of the Future of Alzheimer’s Research

The REGLYDE Clinical Trial represents more than just another research study—it embodies a fundamentally different approach to addressing one of our most challenging health conditions.

Together, we can accelerate the pace of discovery and potentially bring new hope to millions affected by Alzheimer's disease worldwide.

For more information about the REGLYDE Clinical Trial or to stay updated on the crowdfunding campaign launch, visit https://www.ciatrix.com/reglyde.