An observational study in Alzheimer Disease, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 6 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Heinrich-Heine University, Duesseldorf · Observational
This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.
This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. Adverse effects and adverse events without a clear causal relationship will be documented in terms of frequency and severity. Furthermore, the progression of improvement in Alzheimer's symptoms as a result of TPS treatment is summarized in various neuropsychological scales.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
AD Patients undergoing TPS
i. Age = 18 to 85 ii. N>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii. MRI scan, in vivo evidence from CSF and/or PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration [AT(N)], which can be detected on imaging and in biofluids. If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.
iv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist
Exclusion Criteria:
i. Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii. Blood coagulation disorders or oral anticoagulation iii. Epilepsy iv. Medical conditions leading to non-compliance with the protocol
Patients with clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months that have planned treatment with TPS
Diagnostic Test: Registry
Clinical data collection of patients scheduled for on-label treatment
Number of (Serious) Adverse Events
Number of adverse events (without causal relationship to therapy) AE, SAE (query after the first 6-cycle block and before each booster) scaling according to NRS (1-10) for each ADE (query before each stimulation)
Time frame: through study completion, an average of 1 year
Number of adverse device effects
Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)
Time frame: through study completion, an average of 1 year
ADAS
Alzheimer's Disease Asessment Scale (ADAS) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Mini Mental State Examination (MMSE) baseline and follow- up
Mini Mental State Examination (MMSE) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
BDI-II
BDI-II baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Clinical Dementia Rating Sum of Boxes Score (CDR-SB)
Clinical Dementia Rating Sum of Boxes Score (CDR-SB) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL)
Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL) at baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Numeric Rating Scale (NRS) for the main symptom
Numeric Rating Scale (NRS) for the main symptom
Time frame: 12 months
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Heinrich-Heine University, Duesseldorf