Kempen

Researchers are examining the safety and effects of Transcranial Pulse Wave Stimulation TPS as a treatment for Alzheimers disease in a multi-center prospective registry. This Post-Market Clinical Follow-up PMCF study aims to optimize the stimulation protocol while tracking cognitive, emotional, and subjective changes in patients with clinical Alzheimers syndrome. The study also records any adverse events or side effects to better understand the therapys impact. Participants are patients diagnosed with clinical Alzheimers syndrome characterized by progressive memory decline and daily living impairments lasting over six months. They receive TPS treatment supervised by neurological or psychiatric specialists in specialized centers. Optional biomarkers such as MRI, CSF, or PET scans may be used to categorize disease pathology. Data collection focuses on clinical outcomes and treatment effects over an average of one year. During the study, participants undergo evaluations including cognitive tests like the Mini Mental State Examination MMSE, Alzheimers Disease Assessment Scale ADAS, Clinical Dementia Rating scale, depression inventory BDI-II, and daily living activity scales at baseline, after initial treatment sessions, and at intervals up to 12 months. Safety is monitored by recording serious adverse events and device-related effects throughout the study. The total participation duration averages about one year, with ongoing assessments to monitor disease progression and treatment responses.