Alzheimer Disease
Conditions
Keywords
Alzheimer Disease, Transcranial Pulse Wave Stimulation (TPS)
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.
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_TESTRegistry
Clinical data collection of patients scheduled for on-label treatment
Sponsors
Heinrich-Heine University, Duesseldorf
Storz Medical AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of (Serious) Adverse Events | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADAS | Baseline, post first 6 sessions and after 3, 6, 9 and 12 months | 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) |
| Mini Mental State Examination (MMSE) baseline and follow- up | Baseline, post first 6 sessions and after 3, 6, 9 and 12 months | 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) |
| BDI-II | Baseline, post first 6 sessions and after 3, 6, 9 and 12 months | 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) |
| Clinical Dementia Rating Sum of Boxes Score (CDR-SB) | Baseline, post first 6 sessions and after 3, 6, 9 and 12 months | 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) |
| Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL) | 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) 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) |
Countries
Germany
Contacts
CONTACTLars Wojtecki, Prof. Dr.
PRINCIPAL_INVESTIGATORLars Wojtecki, Prof. Dr.
Heinrich-Heine-Universität
Outcome results
None listed