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Recruiting NCT06313944

German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Registry.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)

Overview

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.

Interventions

  • Diagnostic test Registry
    Clinical data collection of patients scheduled for on-label treatment

Primary outcome measures

  • Number of (Serious) Adverse Events [Time frame: through study completion, an average of 1 year]
  • Number of adverse device effects [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Germany · 6 centers
  • Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie — Potsdam
  • Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie — Oldenburg
  • Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen — Bonn
  • Neurologische Praxis Prof. Wojtecki — Neuss
  • Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation — Kempen
  • Praxis Dr. Schwarz — Ulm

Identifiers

NCT: NCT06313944 · GE-R-A-TPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗