Alzheimer DiseaseGE-R-A-TPSNCT06313944
German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
An observational study of Alzheimer Disease, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Registry
- How many people
- 100 participants
- Where
- 6 sitesGermany
- Study dates
- 6 Aug 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AD Patients undergoing TPS
Who may be able to join
- 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.
- TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 5 recruiting
- Not yet recruiting
Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
Bonn, North Rhine-Westphalia, 53127
Ullrich Wüllner, Prof. Dr. med., +49 22828713166, Ullrich.Wuellner@ukbonn.de
- Withdrawn
Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
Kempen, 47906
- Recruiting
Neurologische Praxis Prof. Wojtecki
Neuss, North Rhine-Westphalia, 41460
Lars Wojtecki, Prof. Dr. med., +49 1520 54 53 361, info@brain-clinic.de
- Recruiting
Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie
Oldenburg, Lower Saxony, 26122
Karsten Witt, Prof. Dr. med., +49 441 236 649, karsten.witt@evangelischeskrankenhaus.de
- Recruiting
Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
Potsdam, Brandenburg, 14467
Martin Südmeyer, Prof. Dr. med., +4933124137102, martin.suedmeyer@klinikumevb.de
- Recruiting
Praxis Dr. Schwarz
Ulm, 89073
Alexander Schwarz, Dr. med., +49731922 ext. 6620, kontakt@tps-zentrum.de
About this study
Official title: German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease
- Being tested
- Registry
- Keywords
- Alzheimer Disease, Transcranial Pulse Wave Stimulation (TPS)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryDiagnostic test
Clinical data collection of patients scheduled for on-label treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with Clinical Alzheimer's syndrome treated with TPS | 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 Receives: Diagnostic Test: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start6 Aug 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Storz Medical AG
- Responsible party
- Sponsor
- Investigators
- Lars Wojtecki, Prof. Dr., Principal investigator, Heinrich-Heine-Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313944
- Sponsor's protocol ID
- GE-R-A-TPS
- Acronym
- GE-R-A-TPS
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
- ClinicalTrials.gov ID
- NCT06313944
- Acronym / sponsor ID
- GE-R-A-TPS / GE-R-A-TPS
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Transcranial Pulse Wave Stimulation (TPS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Storz Medical AG
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Clinical Alzheimer's syndrome treated with TPS | – | Diagnostic Test: RegistryPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AD Patients undergoing TPS
Key inclusion criteria (2 listed)
- 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.
- TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryClinical data collection of patients scheduled for on-label treatment | Diagnostic test | Patients with Clinical Alzheimer's syndrome treated with TPS |
Primary outcome
Number of (Serious) Adverse Events
Time frame: through study completion, an average of 1 year
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)
Number of adverse device effects
Time frame: through study completion, an average of 1 year
Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)
5 secondary outcomes
ADAS
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Mini Mental State Examination (MMSE) baseline and follow- up
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
BDI-II
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Clinical Dementia Rating Sum of Boxes Score (CDR-SB)
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)
Time frame: Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Wojtecki, Prof. Dr. principal investigator
Heinrich-Heine-Universität
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Wojtecki, Prof. Dr. (+492118106756, wojtecki@uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of (Serious) Adverse Events (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.