German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Number of (Serious) Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Registry (Diagnostic Test)
结局指标
主要结局
Number of (Serious) Adverse Events
时间窗: 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
时间窗: 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)
次要结局
- Mini Mental State Examination (MMSE) baseline and follow- up(Baseline, post first 6 sessions and after 3, 6, 9 and 12 months)
- BDI-II(Baseline, post first 6 sessions and after 3, 6, 9 and 12 months)
- Clinical Dementia Rating Sum of Boxes Score (CDR-SB)(Baseline, post first 6 sessions and after 3, 6, 9 and 12 months)
- ADAS(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)(Baseline, post first 6 sessions and after 3, 6, 9 and 12 months)