{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T21:08:55Z","timestamp":1791925735109,"version":"4.3.4"},"reference-count":55,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T00:00:00Z","timestamp":1734307200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Chronic Diseases and Translational Medicine"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Substantial research has been conducted to identify an efficient treatment for Alzheimer's disease (AD). Existing treatments, including cholinesterase inhibitors and N\u2010methyl D\u2010aspartate (NMDA) receptor antagonists, do not reverse or slow the disease course but only treat its manifestations. This limitation has brought attention to the need for treatments that modify the amyloid\u2010beta (A\u03b2) and tau pathology of the disease. One recent advancement in AD treatment is donanemab, a monoclonal antibody intended to clear A\u03b2 plaques in the brain. It targets pyroglutamyl(3)\u2010A\u03b2 protein (3\u201342) to remove A\u03b2 deposits and alter the disease course. This review explores the timeline of donanemab use from discovery to clinical use. The pharmacodynamics and pharmacokinetics of the drug are discussed along with typical and suboptimal preclinical and clinical trial results in terms of efficacy, safety, and tolerability. Thus, donanemab is more effective than donepezil and rivastigmine in removing plaques and improving cognition. At the same time, it is not devoid of safety concerns that are typical of the majority of amyloid\u2010targeted medicines. The control to end the treatment after plaque cleaning is a unique selling point for some patients, making it more attractive. The innovation and development of donanemab from research to clinical practice are a clear representation of the role of the field of translational medicine in the practical application of new knowledge in the treatment of AD.<\/jats:p>","DOI":"10.1002\/cdt3.155","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T02:13:29Z","timestamp":1734401609000},"page":"105-116","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Translational Medicine in Alzheimer's Disease: The Journey of Donanemab From Discovery to Clinical Application"],"prefix":"10.1002","volume":"11","author":[{"given":"Nandhini","family":"Jayaprakash","sequence":"first","affiliation":[{"name":"Department of Pharmaceutics, Saveetha Institute of Medical and Technical Sciences, Saveetha College of Pharmacy Saveetha University Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6259-5332","authenticated-orcid":false,"given":"Karthikeyan","family":"Elumalai","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, Saveetha Institute of Medical and Technical Sciences, Saveetha College of Pharmacy Saveetha University Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,16]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2024.102393"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2024.102359"},{"issue":"5","key":"e_1_2_15_4_1","article-title":"Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures","volume":"20","author":"Alzheimer Association","year":"2024","journal-title":"Alzheimer's Association"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12035-023-03730-z"},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2024.102454"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/CON.0000000000001131"},{"key":"e_1_2_15_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/syn.20957"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/1179573520907397"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.9734\/indj\/2023\/v19i1365"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/psyg.12944"},{"key":"e_1_2_15_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2024.102192"},{"key":"e_1_2_15_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2212948"},{"key":"e_1_2_15_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneurol.2017.162"},{"key":"e_1_2_15_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms232213954"},{"key":"e_1_2_15_16_1","doi-asserted-by":"publisher","DOI":"10.1358\/dof.2022.47.4.3389009"},{"key":"e_1_2_15_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-021-01409-2"},{"key":"e_1_2_15_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.21106"},{"key":"e_1_2_15_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare11010032"},{"key":"e_1_2_15_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2875"},{"key":"e_1_2_15_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.0315"},{"key":"e_1_2_15_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.11704"},{"key":"e_1_2_15_23_1","unstructured":"Alzheimer's Disease Forum Donanemab 2024 https:\/\/www.alzforum.org\/therapeutics\/donanemab."},{"key":"e_1_2_15_24_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2021.56"},{"key":"e_1_2_15_25_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2100708"},{"key":"e_1_2_15_26_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.2793"},{"key":"e_1_2_15_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.13239"},{"key":"e_1_2_15_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.082733"},{"key":"e_1_2_15_29_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2021.56"},{"key":"e_1_2_15_30_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.3392"},{"key":"e_1_2_15_31_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.98.18_supplement.1688"},{"key":"e_1_2_15_32_1","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-023-02321-1"},{"key":"e_1_2_15_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.057492"},{"issue":"1","key":"e_1_2_15_34_1","article-title":"Utilization of Published Data & Pharmacokinetic\/Pharmacodynamic Modeling to Evaluate Trial Design: Amyloid Beta Removal & ARIA Incidence Following Anti\u2010Amyloid Beta Therapy in Alzheimer's Disease","volume":"11","author":"Bachhav S. S.","year":"2022","journal-title":"Clinical Pharmacology in Drug Development"},{"key":"e_1_2_15_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/trc2.12404"},{"key":"e_1_2_15_36_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2024.1326784"},{"key":"e_1_2_15_37_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000202956"},{"key":"e_1_2_15_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.2793"},{"key":"e_1_2_15_39_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms241914499"},{"key":"e_1_2_15_40_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.24490"},{"key":"e_1_2_15_41_1","unstructured":"FDA Cder Donanemab for the Treatment of Patients With Early Symptomatic Alzheimer's Disease Sponsor Briefing Document Peripheral and Central Nervous System Drugs Advisory Committee 2024."},{"key":"e_1_2_15_42_1","unstructured":"GlobalData Healthcare AD\/PD 2024: Eli Lilly's donanemab Hit With FDA Delay. Pharmaceutical Technology 2024 https:\/\/www.pharmaceutical-technology.com\/analyst-comment\/ad-pd-2024-eli-lillys-donanemab-hit-with-fda-delay\/."},{"key":"e_1_2_15_43_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13700"},{"issue":"8","key":"e_1_2_15_44_1","first-page":"571","article-title":"FDA Approves Third Anti\u2010Amyloid Antibody for Alzheimer Disease","volume":"23","author":"Mullard A.","year":"2024","journal-title":"Nature"},{"key":"e_1_2_15_45_1","doi-asserted-by":"publisher","DOI":"10.1212\/cpj.0000000000200127"},{"key":"e_1_2_15_46_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2021.1948010"},{"key":"e_1_2_15_47_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD001191"},{"key":"e_1_2_15_48_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1A092"},{"key":"e_1_2_15_49_1","doi-asserted-by":"publisher","DOI":"10.1111\/cns.13035"},{"key":"e_1_2_15_50_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.wad.0000201847.29836.a5"},{"key":"e_1_2_15_51_1","doi-asserted-by":"publisher","DOI":"10.3760\/cma.j.cn341190-20230523-00438"},{"key":"e_1_2_15_52_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1028-4559(09)60303-X"},{"key":"e_1_2_15_53_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2024.102203"},{"key":"e_1_2_15_54_1","doi-asserted-by":"publisher","DOI":"10.2165\/11591860-000000000-00000"},{"key":"e_1_2_15_55_1","doi-asserted-by":"publisher","DOI":"10.1002\/trc2.12382"},{"key":"e_1_2_15_56_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.7230"}],"updated-by":[{"DOI":"10.1002\/cdt3.70063","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T00:00:00Z","timestamp":1787270400000}}],"container-title":["Chronic Diseases and Translational Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cdt3.155","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,6]],"date-time":"2025-06-06T08:54:29Z","timestamp":1749200069000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cdt3.155"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,16]]},"references-count":55,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/cdt3.155"],"URL":"https:\/\/doi.org\/10.1002\/cdt3.155","archive":["Portico"],"relation":{},"ISSN":["2589-0514","2589-0514"],"issn-type":[{"value":"2589-0514","type":"print"},{"value":"2589-0514","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,16]]},"assertion":[{"value":"2024-09-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}