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治疗阿尔茨海默病和痴呆症的新药.pdf

上传人: 明**** 编号:1012322 2025-12-21 41页 3.95MB

1、Newer Treatments for Alzheimers Disease and DementiaJ.Mark Ruscin,Pharm.D.,FCCPProfessor,Dept of Pharmacy PracticeSIUE School of PharmacyMy Background and Perspective Faculty member at SIUE School of Pharmacy since 2008 Previously at Univ of CO School of Pharmacy and Center on Aging(1995 2008)Teachi

2、ng,clinical service,and research interests revolve around the care of older adults John D Ruscin 1927-2024SCIENCE&MEDICINEFDA OKs Alzheimers Disease Treatment:Health Officials say drug is not a cure but that it will offer relief from symptoms for some.It is expected to cost about$1,500 a year.By MAR

3、LENE CIMONSSept.10,1993 12 AM PTTIMES STAFF WRITERWASHINGTON The Food and Drug Administration on Thursday approved the first drug for the treatment of Alzheimers disease,a debilitating brain ailment that robs millions of elderly people of their memory,independence and dignity.https:/ brief look at t

4、he history of FDA drug approvals for Alzheimers Disease(AD)Isoxuprine,cyclandelate,dipyridamole(not FDA approved)Tacrine-First treatment FDA approved for AD 1993Donepezil -FDA approved in 12/1996Rivastigmine-FDA approved in 4/2000Galantamine-FDA approved in 2/2001Memantine-FDA approved in 10/2003Adu

5、canumab*accelerated FDA approval Jan 2021 *(Off market as of Jan 2024)Lecanemab FDA approved 7/2023Donanemab FDA approved 7/2024Benzgalantamine FDA approved 7/2024Cummings J,et al.Alzheimers disease drug development pipeline 2024.Alzheimers Dement.2024;10:e12465“New”Medications Donepezil patch(Adlar

6、ity)5mg or 10mg systems Transdermal administration once weekly(apply to upper back)FDA approved 3/22-acetylcholinesterase inhibitor indicated for the treatment of mild,moderate,and severe dementia of the Alzheimers type Must be refrigerated Clinical implications Avoids first pass metabolism Lower ri

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根据报告的内容,以下是全文关键点的概括: 1. **阿尔茨海默病治疗历史**:自1993年批准首个治疗药物Tacrine以来,FDA已批准多种药物,包括Donepezil、Rivastigmine、Galantamine和Memantine等。 2. **新型药物**: - **Donepezil贴片(Adlarity)**:每周一次给药,减少胃肠道副作用。 - **Benzgalantamine(Zunveyl)**:降低胃肠道副作用,与Galantamine等效。 - **Aducanumab(Aduhelm)**:针对β-淀粉样蛋白,但存在争议,2024年1月自愿撤市。 - **Lecanemab(Leqembi)**:针对β-淀粉样蛋白,2023年7月批准,用于早期症状性阿尔茨海默病。 - **Donanemab(Kisunla)**:针对N-截断的吡咯谷氨酸β-淀粉样蛋白,2024年7月批准。 3. **抗淀粉样蛋白治疗**:Lecanemab和Donanemab均可能导致ARIA(淀粉样蛋白相关成像异常),需监测和管理。 4. **ApoE ε4基因**:与阿尔茨海默病风险增加和ARIA风险增加相关。 5. **其他治疗**: - **Remternetug(LY3372993)**:针对吡咯谷氨酸β-淀粉样蛋白,正在进行III期临床试验。 - **Semaglutide**:GLP-1受体激动剂,正在进行III期临床试验,用于早期阿尔茨海默病。 - **Tau靶向疗法**:包括tau聚集抑制剂、反义寡核苷酸和免疫疗法,正在研究阶段。 6. **成本和支付**:Lecanemab和Donanemab年费用约26,500美元和32,000美元,部分由CMS覆盖。
疗效如何?" 风险与收益?" 未来希望还是挑战?"
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