Clinical trial NCT06989242: Yoga-based, Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.
Official title: Yoga-based, Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.
        The Feasibility and Safety Trial With Preliminary Clinical, Digital, and Fluid Biomarker Proxies of Glymphatic Clearance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment (MCI)
Keywords: Mind-Body Intervention
Medical Device
CSF flow
fNIRS
Feasibility Study
Alzheimer disease
Lead sponsor: CIATRIX, INC.
Sponsor class: INDUSTRY
Collaborators: name: University of Oulu
First posted: 2025-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm interventional feasibility and safety study evaluating a yoga-based therapeutic device in individuals diagnosed with Alzheimer's disease (stages 3 and 4). The intervention combines guided movement and rhythmic breathing. The study assesses feasibility, safety, and preliminary effects on cognitive function, physiological markers (e.g., fNIRS, HRV, posture), and fluid biomarkers.
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Number and type of intervention-related adverse events as assessed by a yoga-specific adverse events questionnaire
timeFrame: Throughout the 4-week intervention period
measure: Number of participants completing ≥90% of scheduled intervention sessions
timeFrame: 4 weeks (intervention period)
measure: Mean percentage of completed intervention sessions per participant
timeFrame: 4 weeks (intervention period)
measure: Number of participants who withdraw from the study before completing intervention
timeFrame: 4 weeks (intervention period)
Secondary outcomes:
measure: Change in Heart Rate Variability During Therapy over time
timeFrame: During each session across 4 weeks
measure: Change in vertical postural alignment as measured by digital posture analysis
timeFrame: Baseline and 4 timepoints altogether corresponding to 4 treatment weeks
measure: Change in spine flexibility as measured by the Thomayer test (in cm)
timeFrame: Baseline and weekly
measure: Change in nightly average heart rate variability (SMSSD) during sleep as measured by wearable sensors in Milliseconds (ms)
timeFrame: Nightly, throughout the 4-week study period
measure: Change in nightly average resting heart rate during sleep as measured by wearable sensors (in bpm)
timeFrame: Nightly, throughout the 4-week study period
measure: Change in nightly average respiratory rate (Breaths per minute) during sleep as measured by wearable sensors
timeFrame: Nightly, throughout the 4-week study period
measure: Change in cortical hemodynamic activity (HbO and HbR concentrations) at rest and during intervention, measured by fNIRS
timeFrame: Baseline, Week 4, and during each intervention session
measure: Change in cortical water signal (tissue hydrodynamics) measured by H2O-specific wavelength sensor
timeFrame: Baseline, Week 4, and during each intervention session
measure: Change in oxidation state of cytochrome c oxidase measured by broadband fNIRS
timeFrame: Baseline, Week 4, and during each intervention session
measure: Change in nightly sleep stage distribution as measured by PPG-based wearable sensors - Percentage of total sleep time in each of the sleep stages
timeFrame: Nightly, over the 4-week intervention period
measure: Change in sleep quality subscale score (B-PSQI) from the GlymphActive Questionnaire
timeFrame: Baseline and Week 4
measure: Change in spatial navigation performance (corrent responses) as measured by the Intersections Spatial Memory Cognitive Task
timeFrame: Familiarization at screening, Baseline and Week 4
measure: Change in global cognitive function as measured by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline and at Week 4
measure: Change in functional ability as measured by the Functional Activities Questionnaire (FAQ-CZ)
timeFrame: Baseline and at Week 4
measure: Change in subjective memory complaints as measured by the McNair Memory Complaint Questionnaire
timeFrame: Baseline and Week 4
measure: Change in anxiety symptoms as measured by the Beck Anxiety Inventory (BAI)
timeFrame: Baseline and Week 4
measure: Change in depressive symptoms as measured by the Geriatric Depression Scale - Short Form (GDS-15)
timeFrame: Baseline and Week 4
measure: Change in Global QoL score as measured by the WHOQOL-BREF
timeFrame: Baseline and Week 4
measure: Change in plasma neurofilament light chain (NfL) concentration
timeFrame: Baseline and Week 4
measure: Change in plasma brain-derived neurotrophic factor (BDNF) concentration
timeFrame: Baseline and Week 4
measure: Change in plasma glial fibrillary acidic protein (GFAP) concentration
timeFrame: Baseline and Week 4
measure: Change in plasma S100 calcium-binding protein B (S100B) concentration
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Neuro Health Centrum S.R.O
city: Prague
country: Czechia
facility: Neuropsychiatrie s.r.o., Terronska 580/19
city: Bratislava
country: Slovakia
facility: AuraMedica s.r.o., Neurologická ambulancia, OMNIA BUSINESS CENTER, Tomášikova 19081/28C
Study officials:
affiliation: Masaryk University, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC), CIATRIX Inc.
name: Patrik Simko, MA. PhD.
role: STUDY_DIRECTOR
affiliation: The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)
name: Katerina Sheardova, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: