PARTICIPANT EXPERIENCE
REGLYDE CLINICAL TRIAL
Learn about the REGLYDE clinical trial and our innovative Fluere™ device, a yoga-based, non-invasive approach aimed at exploring the enhancement of the brain's natural waste-clearance system. This study explores the feasibility and safety of this therapy with the goal of improving well-being and cognitive health.
The REGLYDE Clinical Trial represents a significant step forward in exploring innovative, non-invasive approaches to Alzheimer's disease. This page provides a comprehensive overview of the participant journey, offering transparency for potential participants and their families, as well as detailed procedural insight for the medical and investment communities.
This clinical trial uses the Fluere™ Device, a computer-guided, electro-mechanical system that mimics yoga movements. It dynamically adjusts spinal curvature, similar to movements in certain yoga and Qi Gong practices.
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The primary aim of this study is to evaluate the safety, tolerability, and feasibility of the 4-week Fluere™ program for individuals with Alzheimer's Disease at clinical stage 3 (Mild Cognitive Impairment - MCI) and stage 4 (mild Alzheimer's Disease - mAD).
We are also exploring if this assisted yoga therapy can enhance the brain's glymphatic clearance system, which is responsible for removing metabolic waste. This will be assessed through various measures including heart rate variability, sleep quality, cognition, plasma biomarkers, and fNIRS technology.
About The Study
This clinical trial investigates the safety, tolerability, and feasibility of the Fluere™ therapy (a computer-guided device that mimics yoga movements) for individuals with early-stage Alzheimer’s disease (AD stages 3 and 4). Over four weeks, participants receive 12 sessions combining movement, rhythmic breathing, and music-guided relaxation.
What We're Studying
The primary goals are to assess how well participants tolerate the therapy and whether a longer regimen is feasible. Secondary goals include monitoring improvements in posture, heart rate variability, sleep quality, cognitive function, and key biomarkers of neurodegeneration.
Study Duration
The treatment period will last for 4 weeks, involving a total of 12 therapy sessions. There is typically a one-week interval between the initial screening visit (T0) and the first therapy session (T1).
REGLYDE Therapy Session
Initial
Relaxation
Participants lie in the Fluere™ device, guided by music and breathing cues to induce relaxation
5 minutes
Movement
with Relaxation
The device initiates subtle, precise movements synchronized with breathing
5 minutes
Main
Session
Breathing cues stop, while the gentle, steady motion and music continues
25 minutes
Cool Down
Phase
The device stops moving, the patient remains reclined, allowing the body to self-regulate and integrate the therapy
10 minutes
T0: INITIAL VISIT
Approximately 1.5 to 2 hours
The initial visit is designed to ensure each participant’s comfort, safety, and informed understanding of the study. During this comprehensive session, we conduct medical, cognitive, and movement assessments to establish a personalized baseline before beginning therapy
Informed Consent
The patient reviews and signs the informed consent form.
Medical Evaluation
A medical doctor conducts a comprehensive check-up, assessing possible exclusion criteria, medical history, and concomitant medications.
Patient Staging
Patients with relevant biomarkers are recruited, and their disease progression stage is identified as AD-MCI (stage 3) or mAD (stage 4).
Musculoskeletal Evaluation
Posture assessment (posture grid) and spinal flexibility test (Thomayer test), categorizing the patient into one of two groups.
Vital Signs
Vital signs are recorded, including blood pressure, heart rate, and respiratory rate, as well as height and weight.
Cognitive Screening
A psychologist administers the Mini-Mental State examination to assess cognitive function and helps complete questionnaires related to memory, anxiety, depression, and quality of life.
Blood-Sample Collection
A blood sample is collected from the patient for biomarker analysis.
Task Familiarization
Participants are introduced to the Spatial Memory Task
Resting State fNIRS
A protocol designed by the University of Oulu (UoO) is conducted to measure resting-state brain activity.
Device Calibration
The participant is familiarized with the device and the device is calibrated to the participant’s maximal flexion and extension position.
PPG Placement
The PPG sensor is handed over to the participant for continuous physiological monitoring.
T1: FIRST THERAPY SESSION
Approximately 1.5 hours
The first therapy session introduces participants to the movement-based intervention in a calm and structured environment. It combines guided breathing, gentle motion, and baseline assessments to ensure comfort, safety, and accurate data collection.
Spatial Memory Task
Participants complete the baseline version of the Spatial memory task.
Pre-Session Vital Signs
Blood Pressure, Heart and Respiratory Rate are recoded.
fNIRS Preparation
The fNIRS device is mounted for neuroimaging during therapy.
Main Session
Participants recline as music and breathing cues guide gentle, rhythmic movements, then conclude with a cool-down and stretching to promote relaxation.
Post-Session Vital Signs
Blood Pressure, Heart and Respiratory rate are recorded.
Adherence and YSAEQ
Participants report adherence and answer the Yoga-specific Adverse Event Questionnaire, monitoring potential side effects.
Sleep Assessment
Participants complete sleep-related questionnaires provided by the University of Oulu.
Posture Evaluation
A picture is taken of the participant in front of a posture grid.
T2-12: (2ND TO 12TH THERAPY SESSIONS)
Approximately 1 hour
Each weekly session follows a consistent structure that supports both safety and progress tracking. It includes vital sign monitoring, the therapy session itself, and follow-up assessments such as posture evaluation, sleep review, and side effect reporting.
AE Reporting, Vital Signs
Each weekly session includes adverse event reporting and pre-session vital sign measurements.
fNIRS Preparation
The fNIRS device is mounted for neuroimaging during therapy.
Main Session
Participants recline as music and breathing cues guide gentle, rhythmic movements, then conclude with a cool-down and stretching to promote relaxation.
Post-Session Vital Signs
Blood Pressure, Heart and Respiratory rate are recorded.
Adherence and YSAEQ
After each session, participants report adherence and answer the Yoga-specific Adverse Event Questionnaire, monitoring potential side effects.
Sleep Assessment
Participants complete sleep-related questionnaires provided by the University of Oulu.
Posture Evaluation
A picture is taken of the participant in front of a posture grid.
EOT: END OF TREATMENT
Approximately 1.5 to 2 hours
The final session brings together all closing assessments to evaluate changes and outcomes. It includes a last therapy session, vital sign monitoring, biomarker collection, cognitive testing, and final evaluations of posture, flexibility, and well-being.
AE Reporting, Vital Signs
Participants complete the baseline version of the Spatial memory task.
fNIRS Preparation
The fNIRS device is mounted for neuroimaging during therapy.
Last Therapy Session
Participants recline as music and breathing cues guide gentle, rhythmic movements, then conclude with a cool-down and stretching to promote relaxation.
Post-Session Vital Signs
Vital signs are recorded, including blood pressure, heart rate, and respiratory rate, as well as height and weight.
Blood Biomarkers
A blood sample is collected from the patient for biomarker analysis.
Adherence and YSAEQ
After each session, participants report adherence and answer the Yoga-specific Adverse Event Questionnaire, monitoring potential side effects.
Sleep Assessment
Participants complete sleep-related questionnaires provided by the University of Oulu.
End of PPG Monitoring
The PPG sensor monitoring period is concluded.
Resting State fNIRS
A final resting state near-infrared spectroscopy scan is performed.
Posture Assessment
Posture and spinal flexibility are reevaluated to assess changes.
Cognitive Assessment
Final cognitive testing, including the Spatial Memory Task and post-intervention questionnaires are administered, covering memory, anxiety, depression, and quality of life.
Join Us in This Transformative Journey
Ciatrix will be launching a crowdfunding campaign to fund the expansion of the REGLYDE Clinical Study and bring this vision to life. By supporting us, you’ll play a vital role in helping us pioneer this research and stay informed of our progress every step of the way. Together, we can explore a new frontier in Alzheimer’s care.