METHODS: In a prospective, one-arm open-label trial, ten patients with mild to moderate dementia due to AD were assessed using the Alzheimer\'s Disease Assessment Scale (ADAS-Cog), Neuropsychiatric Inventory (NPI), Pfeffer Functional Activities Questionnaire, and Zarit Caregiver Burden Interview. Assessments occurred at 30- and 90-days post-treatment. The TPS protocol consisted of 10 sessions over five weeks, using the Neurolith® device to deliver 6000 focused shockwave pulses at 0.25 mJ/mm2 and a frequency of 4 Hz.
RESULTS: TPS significantly reduced neuropsychiatric symptoms, with NPI scores decreasing by 23.9 points (95% CI: -39.19 to -8.61, p = 0.0042) after 30 days, and by 18.9 points (95% CI: -33.49 to -2.91, p = 0.022) after 90 days. These changes had large effect sizes (Cohen\'s dz = 1.43 and dz = 0.94, respectively). A decreasing trend was observed in the ADAS-Cog score (-3.6, 95% CI: -7.18 to 0.00, p = 0.05) after 90 days, indicating a potential reduction in cognitive impairment, though not statistically significant.
CONCLUSIONS: The preliminary results indicate that TPS treatment leads to significant improvement in neuropsychiatric symptoms in AD patients, showing promise as a therapeutic approach for AD. Further research is needed to fully establish its effectiveness, especially concerning cognitive functions.
方法:在前瞻性中,单臂开放标签试验,使用阿尔茨海默病评估量表(ADAS-Cog)评估了10例因AD引起的轻度至中度痴呆的患者,神经精神量表(NPI),Pfeffer功能活动问卷,和Zarit照顾者负担访谈。评估发生在治疗后30天和90天。TPS协议包括五周的10次会议,使用Neurolith®设备以0.25mJ/mm2和4Hz的频率提供6000个聚焦冲击波脉冲。
结果:TPS显著减轻神经精神症状,30天后,NPI评分下降23.9分(95%CI:-39.19至-8.61,p=0.0042),90天后下降18.9分(95%CI:-33.49至-2.91,p=0.022)。这些变化具有大的效应大小(分别为Cohen的dz=1.43和dz=0.94)。90天后ADAS-Cog评分呈下降趋势(-3.6,95%CI:-7.18至0.00,p=0.05),表明认知障碍的潜在减少,虽然没有统计学意义。
结论:初步结果表明,TPS治疗可显著改善AD患者的神经精神症状,显示出作为AD治疗方法的希望。需要进一步研究以充分确立其有效性,尤其是关于认知功能。