NCT06313944 German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
| NCT ID | NCT06313944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-08-06 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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
Contact & Investigator
Lars Wojtecki, Prof. Dr.
PRINCIPAL INVESTIGATOR
Heinrich-Heine-Universität
Frequently Asked Questions
Who can join the NCT06313944 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06313944 currently recruiting?
Yes, NCT06313944 is actively recruiting participants. Contact the research team at wojtecki@uni-duesseldorf.de for enrollment information.
Where is the NCT06313944 trial being conducted?
This trial is being conducted at Potsdam, Germany, Bonn, Germany, Kempen, Germany, Ulm, Germany.
Who is sponsoring the NCT06313944 clinical trial?
NCT06313944 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Lars Wojtecki, Prof. Dr. at Heinrich-Heine-Universität. The trial plans to enroll 100 participants.
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