NCT06989242

Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.

Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease. The Feasibility and Safety Trial With Preliminary Clinical, Digital, and Fluid Biomarker Proxies of Glymphatic Clearance

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CIATRIX, INC. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates a yoga-based intervention delivered through a powered therapeutic device designed to guide breathing and body movements. Building on evidence that mind-body practices may promote healthy aging, cognitive function, and glymphatic flow, the study uses physiological measurements, including fNIRS and wearable sensors, to investigate mechanisms and potential benefits in individuals at risk for Alzheimer's disease.

Detailed description

Brief Summary: The current trial builds on recent findings that highlight the effectiveness of mind-body interventions, such as yoga and deep abdominal breathing, in promoting healthy aging and slowing cognitive decline. Research suggests that yoga and body-mind practices can improve well-being and reduce biological markers of aging in both healthy older adults and those at risk for dementia. Yogic breathing and body movements may enhance cerebrospinal fluid (CSF) flow as an important component of the glymphatic function. The trial employs physiological measurements, including fNIRS and wearable sensors, to investigate the mechanisms and clinical benefits of yoga-based interventions for AD. The primary objective is to assess the safety, tolerability, feasibility of a 4-week Fluere™ therapy protocol for stage 3 and 4 AD patients. The secondary objectives focus on clinical effectiveness related to: 1. Body posture improvement 2. Changes in HRV (reflecting the stress level and quality of sleep) Although the duration of the study is short, and the study is not powered to detect changes in biomarkers or clinical efficacy, secondary endpoints will be analyzed to assess trends in improvement from baseline. Additional secondary outcomes will focus on biomarker proxies of glymphatic clearance: 1. Impact on digital biomarkers (neuro-fluid dynamics (hemodynamics, CSF) and redox state of cytochrome-c-oxidase activity using fNIRS) 2. Effect on plasma biomarkers associated with neurodegeneration, inflammation and neural plasticity - GFAP, NfL and S100B and BDNF 3. Cognitive (spatial memory) and functional outcomes 4. Sleep patterns and quality through wearable devices and questionnaires

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment (MCI)

Interventions

Type	Name	Description
DEVICE	Yoga-Based Therapeutic Device (incorporating guided breathing and movement)	The Fluere™ Therapeutic Device is a computer-guided, electro-mechanical system designed to simulate yoga-inspired spinal movement and rhythmic breathing. Resembling a dental chair, the device dynamically adjusts spinal curvature to replicate motion patterns associated with deep abdominal breathing, similar to Kundalini or Qi Gong breathwork. The device operates automatically, with optional manual adjustments by the researcher.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-02-28
• Completion: 2026-05-01
• First posted: 2025-05-25
• Last updated: 2025-07-10

Locations

3 sites across 2 countries: Czechia, Slovakia