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

CIATRIX, INC.

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease

Treatments: Device: Yoga-Based Therapeutic Device (incorporating guided breathing and movement)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06989242

RG-CZSK-PH2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 55-85 years of age
• Current diagnostic criteria for stage 3 AD patients (AD-MCI)
• Current diagnostic criteria for stage 4 AD patients (mAD)
• Able to provide consent to be in the study
• Willing and able to participate in study activities
• Able to lay supine for 30-45 minutes
• Able to walk 20 meters
• Willing to not perform additional mind-body practices during the duration of the study
• Able to use a wearable electronic device (Smart watch)

Exclusion criteria

• Inability to provide informed consent
• Regular use of muscle relaxants or anti-anxiety drugs
• Any muscle or skeletal issues that would make it difficult to lie still in the supine position for the 1-hour physical therapy
• Craniospinal disorders, e.g., Chiari Malformation.
• Spinal injuries, clinically relevant disc herniation, spinal stenosis, spondylolisthesis in the sacral, lumbar, thoracic, or cervical spine, spinal bifida, Recent Spinal Surgery
• Severe osteoporosis with a risk of fracture
• History of neurological disorders such as stroke (during the last year before study start), mild brain injury within past 6 months, multiple sclerosis, presence of intracranial hemorrhage, hydrocephalus, meningitis, encephalitis, brain tumor (except of asymptomatic meningioma GI)
• Serious sleep disorders - narcolepsy
• Major or uncontrolled psychiatric illness or major depression.
• Any condition requiring the use of medication that acts on the brain such as stimulants, sedatives (hypnotics and benzodiazepines), antipsychotics, and anti-anxiety medications, (we will include patients with stable antidepressant treatment and being on mild anti-seizure medication due to polyneuropathy)
• Active infection or uncontrolled significant systemic illnesses
• Asthma, chronic obstructive pulmonary disease
• Recent hearth attack, Implantable defibrillator, poorly controlled blood pressure cardiac arrhythmia, unstable angina pectoris, or symptomatic congestive heart failure
• People at risk of blood clots or deep vein thrombosis (DVT) might want to avoid prolonged sitting in the chair
• Obesity over 135 kg (300lb)
• Smoking more than 5 cigarettes a day or drinking more than 1 alcoholic beverage a day

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention Arm - Device-Guided Movement and Breathing

Experimental group

Description:

Participants in this arm will receive a yoga-based intervention delivered through a powered therapeutic device that guides rhythmic breathing and spinal movement. The intervention is designed to mimic traditional yoga poses such as Marjariasana (cat-cow) and is conducted over multiple sessions. The study aims to assess feasibility, safety, and preliminary effects on cognitive function, physiological measures (e.g., fNIRS, HRV, posture), and fluid biomarkers in individuals with Alzheimer's disease (stages 3 and 4).

Treatment:

Device: Yoga-Based Therapeutic Device (incorporating guided breathing and movement)