REGLYDE Clinical Trial Registered on ClinicalTrials.gov: A New Approach in Alzheimer’s Research
- Ciatrix Research Team
- Jun 3
- 5 min read
For families facing Alzheimer’s, even a small step forward can feel like a lifeline. At Ciatrix, we’re exploring a new direction, one that uses the brain’s natural ability to heal itself by focusing on increasing the flow of cerebrospinal fluid (CSF), which could help the brain clear out the toxic proteins that contribute to the disease.
We’re excited to share that our clinical trial, REGLYDE, is now listed on ClinicalTrials.gov (NCT06989242).
Starting in July 2025, this early Phase I/II feasibility and safety study is designed to inform future efficacy trials by evaluating whether our investigational device, Fluere™, can help support brain health in individuals with early to mild Alzheimer’s disease (Stage 3 and 4 AD).
Why New Therapies Are Essential for Alzheimer’s
Alzheimer’s disease affects more than 57 million people worldwide and places an immense emotional and physical burden on families.¹ Current treatments can help manage symptoms but do not target the underlying mechanisms that drive the disease.
Every 3 seconds someone in the world develops dementia, despite decades of research and billions in funding, there's still no cure.²
At Ciatrix, we believe that interventions aimed at restoring or enhancing the brain’s own clearance systems could change the landscape of Alzheimer’s care.
With the REGLYDE Clinical Trial, we’re investigating how biomechanics, yoga-inspired motion, and relaxation techniques might work together to support brain health.
The Fluere™ Device and the Glymphatic System Approach
The glymphatic system is the brain’s waste clearance network, often described as its ‘garbage disposal.’ It removes metabolic waste, including amyloid-beta and tau proteins. When this system slows, these proteins can accumulate and contribute to neurodegenerative diseases such as Alzheimer’s.
Research suggests that certain breathing patterns and spinal movements can enhance cerebrospinal fluid (CSF) flow, which in turn supports glymphatic function. However, delivering these movements consistently is difficult, especially for individuals with cognitive decline. ³ ⁴
That’s where REGLYDE comes in. Unlike traditional drug-based therapies, REGLYDE uses a novel, non-invasive approach to stimulate the brain’s clearance systems through gentle, guided motion and breath.
Our investigational device, Fluere™, is a computer-controlled system that gently guides participants through yoga-inspired spinal motions synchronized with paced breathing. The REGLYDE trial will evaluate whether this intervention can enhance CSF dynamics and support brain waste clearance. Researchers will also track biomarker changes linked to neurodegeneration to assess its therapeutic potential.
Details of the REGLYDE Feasibility and Safety Clinical Trial
Study Design
The REGLYDE Clinical Trial is a single-arm, open-label feasibility and safety trial. The study plans to enrol 60 participants across three centres. Its primary goals are to evaluate safety and feasability. While clinical efficacy is not the main endpoint in this phase, our team will also collect preliminary data on physiological and cognitive measures to guide future studies.
Study Locations
We have selected three established academic medical centers in Europe:
Neuro Health Centrum s.r.o., (Brno, Czechia)
Neuropsychiatrie s.r.o., (Prague, Czechia)
AuraMedica s.r.o., (Bratislava, Slovakia)
Each site has experience conducting neurodegenerative clinical trials and is fully equipped with functional near-infrared spectroscopy (fNIRS) and wearable sensor capabilities.
Enrollment Criteria
Age 55 – 85 years
Diagnosed with stage 3 Alzheimer’s (Mild Cognitive Impairment due to Alzheimer’s, or AD-MCI) or stage 4 Alzheimer’s (mild Alzheimer’s dementia)
Medically stable and able to attend three visits per week for four consecutive weeks
Eligible participants will receive 12 Fluere™ therapy sessions (three sessions per week for four weeks). Each session lasts approximately 45 minutes, including initial relaxation, device-guided movements, and a cool down phase.
To dive deeper into the participant experience, including the detailed steps of the REGLYDE trial from initial screening to final assessments, visit our participant journey page.
How We Are Measuring Outcomes
To ensure clarity and transparency, we have divided our outcome measures into Primary and Secondary/Exploratory categories.
Primary Outcomes
Secondary & Exploratory Outcomes
Our Commitment to Research Standards
Ciatrix is fully committed to upholding rigorous research standards.
According to our Clinical Investigation Plan, Fluere™ is classified as a Non-Significant Risk device, is currently FDA-registered, and remains investigational without marketing approval.
REGLYDE operates under EU Medical Device Regulation and follows internationally recognized clinical research guidelines, including ISO 14155, the Declaration of Helsinki, and Good Clinical Practice. Every investigator has signed an agreement confirming they will conduct the study exactly as described in the approved protocol, adhere to ethical principles, and comply with all applicable local laws.
Before enrolling any volunteers, each site’s Ethics Committee and the relevant national health authority reviewed and approved the complete protocol and consent forms. An independent Data and Safety Monitoring Board meets on a regular schedule to review safety data and any unexpected device-related events. Should any significant concern arise, the board has the authority to recommend protocol modifications or temporarily pause recruitment.
Ciatrix Clinical Trial Monitors (or designee) will conduct on-site visits at each location to confirm informed consent, verify eCRFs against source documents, and monitor adverse event reporting.
Participant information is maintained under coded IDs so that personal details remain confidential in accordance with local data protection regulations. We are also collaborating with the University of Oulu, who will conduct fNIRS data collection and analysis to estimate cortical hemodynamics and fluid shifts.
Sources:
³ Aktas, G., Kollmeier, J.M., Joseph, A.A. et al. Spinal CSF flow in response to forced thoracic and abdominal respiration. Fluids Barriers CNS 16, 10 (2019). https://doi.org/10.1186/s12987-019-0130-0
⁴ Vidhya Vijayakrishnan Nair, Tyler C. Diorio, Qiuting Wen, Vitaliy L. Rayz, Yunjie Tong; Using respiratory challenges to modulate CSF movement across different physiological pathways: An fMRI study. Imaging Neuroscience 2024; 2 1–14. doi: https://doi.org/10.1162/imag_a_00192
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