Kempen

Researchers are evaluating the safety and potential effects of Transcranial Pulse Wave Stimulation (TPS) for treating Alzheimer's disease in a post-market clinical follow-up study. This multicenter, prospective data collection aims to optimize the stimulation protocol while documenting the frequency and severity of adverse effects and events. The study also tracks changes in cognitive, affective, and subjective scores to understand the impact of TPS on Alzheimer's symptoms. Participants scheduled for on-label TPS treatment will have their clinical data collected as part of this registry. The treatment is provided under the supervision of a neurological or psychiatric specialist at specialized centers. MRI scans and biomarker evidence from cerebrospinal fluid or PET imaging may be included when possible to support the diagnosis and categorization of Alzheimer's disease or its continuum. During the study, researchers will monitor participants for serious and non-serious adverse events related to the device over about one year. They will assess changes in neuropsychological scales that reflect improvements or progression in Alzheimer's symptoms. The study focuses on safety outcomes and gathers data on cognitive and affective functions to evaluate TPS applicability and effects over the course of treatment and follow-up.