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Search / Trial NCT06989242

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

Launched by CIATRIX, INC. · May 15, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Mind Body Intervention Medical Device Csf Flow F Nirs Feasibility Study Alzheimer Disease

ClinConnect Summary

This clinical trial is exploring a unique yoga-based program that uses a special device to help guide breathing and body movements. The goal is to see if this approach can improve brain health and help with conditions like Alzheimer’s disease and mild cognitive impairment (MCI). Researchers believe that practices combining the mind and body may support healthy aging and cognitive function, so they will use high-tech sensors to measure how effective this intervention is for individuals at risk for Alzheimer’s.

To participate, individuals need to be between 55 and 85 years old and diagnosed with early stages of Alzheimer’s or mild cognitive impairment. They should be able to provide consent, participate in activities, lie down comfortably for 30-45 minutes, and walk a short distance. Participants will need to avoid other mind-body practices during the study and should be comfortable using a smartwatch. It's important to note that some health conditions, such as recent neurological issues or certain heart problems, might exclude someone from participating. If you or a loved one are interested, feel free to ask for more information!

Gender

ALL

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

About Ciatrix, Inc.

Ciatrix, Inc. is a pioneering clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient outcomes and accelerating drug development, Ciatrix leverages cutting-edge technologies and methodologies to streamline clinical trials across various therapeutic areas. The company is committed to upholding the highest standards of ethical practices and regulatory compliance, ensuring that all studies are conducted with integrity and transparency. By fostering collaboration with healthcare professionals and stakeholders, Ciatrix aims to bring transformative treatments to market, ultimately improving the quality of life for patients worldwide.

Locations

Brno, , Czechia

Prague, , Czechia

Bratislava, , Slovakia

Patients applied

0 patients applied

Trial Officials

Patrik Simko, MA. PhD.

Study Director

Masaryk University, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC), CIATRIX Inc.

Katerina Sheardova, MD. PhD.

Principal Investigator

The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported