References
- Rajan KB, Weuve J, Barnes LL, et al. Population estimate of people with clinical Alzheimer’s disease and mild cognitive impairment in the United States (2020–2060). Alzheimer’s & dementia. 2021;17(10):342. doi: 10.1002/alz.12362
- US Census Bureau. 2014. National population projections datasets [Internet]. Census.gov. [cited 2023 Sep 18]. Available from: https://www.census.gov/data/datasets/2014/demo/popproj/2014-popproj.html
- Khoury R, Ghossoub E. Diagnostic biomarkers of Alzheimer’s disease: a state-of-the-art review. Biomark Neuropsychiatry. 2019;1:100005. doi: 10.1016/j.bionps.2019.100005
- Jack Jr CR, Bennett DA, Blennow K, et al. NIA-AA research framework: toward a biological definition of Alzheimer’s disease. Alzheimer’s & Dementia. 2018;14(4):535–562. doi: 10.1016/j.jalz.2018.02.018
- Hampel H, Elhage A, Cho M, et al. Amyloid-related imaging abnormalities (ARIA): radiological, biological and clinical characteristics. Brain. 2023;146(11):4414–4424. doi: 10.1093/brain/awad188
- Souchet B, Michaïl A, Billoir B, et al. Biological diagnosis of Alzheimer’s disease based on amyloid status: an illustration of confirmation bias in medical research? Int J Mol Sci. 2023 Dec 16;24(24):17544. doi: 10.3390/ijms242417544
- Rasmussen J, Langerman H. Alzheimer’s disease – why we need early diagnosis. Degenerative neurological and neuromuscular disease. Internet. 2019;9:123–130. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935598/
- Larkin HD. Lecanemab gains FDA approval for early Alzheimer disease. JAMA. 2023 Feb 7;329(5):363. doi: 10.1001/jama.2022.24494
- FDA. FDA converts novel Alzheimer’s disease treatment to traditional approval [internet]. FDA. 2023 [cited 2023 Sep 18]. Available from: https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval
- FDA: highlights of prescribing information. LEQEMBI® [Internet]. accessdata.fda.gov. 2023 [cited 2023 Sep 18]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf
- Cummings J, Apostolova L, Rabinovici GD, et al. Lecanemab: appropriate use recommendations. J prev Alzheimer’s dis. 2023;1–6; doi: 10.14283/jpad.2023.30
- Brookmeyer R, Johnson E, Ziegler-Graham K, et al. Forecasting the global burden of Alzheimer’s disease. Alzheimer’s & Dementia. 2007;3(3):186–191. doi: 10.1016/j.jalz.2007.04.381
- Tahami Monfared AA, Phan NTN, Pearson I, et al. A systematic review of clinical practice guidelines for Alzheimer’s disease and strategies for future advancements. Neurol Ther. 2023;12(4):1257–1284. doi: 10.1007/s40120-023-00504-6
- Padda IS, Parmar MA. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing 2024 Jan [cited 2023 Jun 3]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK573062/
- Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA Internet. 2023;330(6):512. Available from: https://jamanetwork.com/journals/jama/fullarticle/2807533?guestAccessKey=855d51a0-c676-46f8-8bb3-1ecaa471d5eb&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=071723
- Karran E, De Strooper B. The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics. Nat Rev Drug Discov. 2022 21;21(4):306–318. doi: 10.1038/s41573-022-00391-w
- Zhang Y, Chen H, Li R, et al. Amyloid β-based therapy for Alzheimer’s disease: challenges, successes and future. Signal Transduct Target Ther Internet. 2023;8(1):1–26. [cited 2023 Aug 2]. Available from: https://www.nature.com/articles/s41392-023-01484-7
- Söderberg L, Johannesson M, Nygren P, et al. Lecanemab, Aducanumab, and Gantenerumab - binding profiles to different forms of amyloid-β might explain efficacy and side effects in clinical trials for Alzheimer’s disease. Neurotherapeutics. 2023 Jan;20(1):195–206. doi: 10.1007/s13311-022-01308-6
- Nilsberth C, Westlind-Danielsson A, Eckman CB, et al. The ’Arctic’ APP mutation (E693G) causes Alzheimer’s disease by enhanced Aβ protofibril formation. Nat neurosci. 2001;4(9):887–893. doi: 10.1038/nn0901-887
- Johannesson M, Sahlin C, Söderberg L, et al. Elevated soluble amyloid β protofibrils in down syndrome and Alzheimer’s disease. Mol Cell Neurosci. 2021;114:103641.
- Swanson CJ, Zhang Y, Dhadda S, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody. Alz Res Therapy. 2021;13(1). doi: 10.1186/s13195-021-00813-8
- McDade E, Cummings JL, Dhadda S, et al. Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimer’s Res Ther Internet. 2022;14(1). doi: 10.1186/s13195-022-01124-2
- van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med Internet. 2023;3881:9–21. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
- Cohen S, Cummings J, Knox S, et al. Clinical trial endpoints and their clinical meaningfulness in early stages of Alzheimer’s disease. J Prev Alzheimers Dis. 2022;9(3):507–522. doi: 10.14283/jpad.2022.41
- U.S. Food and Drug Administration (FDA). Alzheimer’s disease: developing drugs for treatment guidance for industry. 2018. [cited 2024 Feb 21]. Available from: https://www.fda.gov/files/drugs/published/Alzheimer%E2%80%99s-Disease—Developing-Drugs-for-Treatment-Guidance-for-Industy.pdf
- Liu KY, Schneider LS, Howard R. The need to show minimum clinically important differences in Alzheimer’s disease trials. Lancet Psychiatry. 2021;8(11):6. pmid:34087114 doi: 10.1016/S2215-0366(21)00197-8
- Logovinsky V, Satlin A, Lai R, et al. Safety and tolerability of BAN2401 - a clinical study in Alzheimer’s disease with a protofibril selective Aβ antibody. Alzheimer’s Res Ther Internet. 2016;8(1). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4822297/
- Rafii MS, Sperling RA, Donohue MC, et al. The AHEAD 3‐45 study: design of a prevention trial for Alzheimer’s disease. Alzheimer’s Dementia. 2022;19.
- Tarawneh R, Pankratz VS. The search for clarity regarding “clinically meaningful outcomes” in Alzheimer disease clinical trials: CLARITY-AD and beyond. Alzheimers Res Ther. 2024 Feb 16;16(1):37. doi: 10.1186/s13195-024-01412-z
- Filippi M, Cecchetti G, Spinelli EG, et al. Amyloid-related imaging abnormalities and β-amyloid–Targeting antibodies: a systematic review. JAMA Neurol. 2022;79(3):291–304. doi: 10.1001/jamaneurol.2021.5205
- Jeong SY, Suh CH, Shim WH, et al. Incidence of amyloid-related imaging abnormalities in patients with Alzheimer disease treated with anti–β-Amyloid immunotherapy: a meta-analysis. Neurology Internet. 2022;99(19):e2092–e2101. [cited 2022 Dec 15]. Available from: https://n.neurology.org/content/99/19/e2092.abstract
- Loomis SJ, Miller R, Castrillo-Viguera C, et al. Genome-wide association studies of ARIA from the aducanumab phase 3 ENGAGE and EMERGE studies. Neurology. 2024 Feb 13;102(3):e207919. doi: 10.1212/WNL.0000000000207919
- U.S. FDA Biologics license application approval letter to Eisai Inc. Dated Jan 6, 2023. [cited 2024 Feb 20]. Available from: https://www.accessdata.fda.gov/drugsatfdadocs/appletter/2023/761269Orig1s000ltr.pdf
- European Medicines Agency. Human medicines division committee for medicinal products for human use (CHMP) [Internet]. 2023 [updated 2023 Sep 18; cited 2024 Feb 20]. Available from: https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-11-14-september-2023_en.pdf
- Otake T Japanese ministry panel gives OK to Alzheimer’s drug lecanemab [internet]. The Japan Times. 2023 [cited 2023 Sep 18]. Available from: https://www.japantimes.co.jp/news/2023/08/21/japan/science-health/lecanemab-alzheimers-drug-approval/
- Walsh S, Merrick R, Richard E, et al Lecanemab for Alzheimer’s disease. BMJ. 2022;379:o3010. doi: 10.1136/bmj.o3010