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

Alzheimer Disease Clinical Trial

— GE-R-A-TPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313944
• Other study ID #: GE-R-A-TPS
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Lars Wojtecki, Prof. Dr.
• Phone: +492118106756
• Email: wojtecki[@]uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Storz Medical AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric Rating Scale (NRS) for the main symptom	Numeric Rating Scale (NRS) for the main symptom	12 months
Primary	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)	through study completion, an average of 1 year
Primary	Number of adverse device effects	Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)	through study completion, an average of 1 year
Secondary	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)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Secondary	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)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Secondary	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)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Secondary	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)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months
Secondary	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)	Baseline, post first 6 sessions and after 3, 6, 9 and 12 months