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Mild Cognitive Impairment Market Anticipated to Expand Rapidly During 2024-2034, Says DelveInsight
Mild Cognitive Impairment Market Anticipated to Expand Rapidly During 2024-2034, Says DelveInsight

Globe and Mail

time01-08-2025

  • Health
  • Globe and Mail

Mild Cognitive Impairment Market Anticipated to Expand Rapidly During 2024-2034, Says DelveInsight

The Key Mild Cognitive Impairment Companies in the market include - FUJIFILM Toyama Chemical Co. Ltd., Aptinyx, AgeneBio, Eisai Inc., RespireRx, Allon Therapeutics, CuraSen Therapeutics, Inc., Avraham Pharma, AstraZeneca, Sage Therapeutics, Pfizer, Materia Medica Holding, Eli Lilly and Company, GE Healthcare, Parexel, and others. DelveInsight's 'Mild Cognitive Impairment Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Mild Cognitive Impairment, historical and forecasted epidemiology as well as the Mild Cognitive Impairment market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. Some of the key facts of the Mild Cognitive Impairment Market Report: The Mild Cognitive Impairment market size was valued ~USD 2,836 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034). In April 2025, At the AD/PD 2025 International Conference on Alzheimer's and Parkinson's Diseases, Alzheon shared findings from its Phase III APOLLOE4 (NCT04770220) trial during a company-sponsored symposium. The study evaluated ALZ-801 (valiltramiprosate), an oral small molecule that blocks the formation of neurotoxic amyloid beta (Aβ) oligomers, in patients with early-stage Alzheimer's disease—specifically those with mild cognitive impairment (MCI) or mild Alzheimer's—who are homozygous carriers of the APOE4 gene. In December 2024, Blarcamesine (ANAVEX2-73) has been accepted for review by the EMA for the treatment of Alzheimer's disease. This submission was supported by positive findings from the ANAVEX2-73-AD-004 clinical trial, which involved patients in the early stages of Alzheimer's. As of December 2024, TauRx is actively engaging with the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) concerning its UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM), a 4 mg oral tablet aimed at treating mild cognitive impairment due to Alzheimer's (MCI-AD) and mild to moderate Alzheimer's disease. In July 2024, The US FDA has granted approval to KISUNLA (donanemab-azbt, 350 mg/20 mL), an Alzheimer's treatment developed by Eli Lilly. The therapy is intended for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment (MCI) and mild dementia confirmed to have amyloid pathology. In October 2024, AgeneBio reported that its Phase 2B trial of AGB101 showed a 40% reduction in clinical decline and notable slowing of entorhinal cortex atrophy in patients with mild cognitive impairment (MCI) due to Alzheimer's disease who are non-carriers of the ApoE-4 allele, compared to placebo. The ongoing findings from the HOPE4MCI trial strongly support continued evaluation of AGB101 in this specific patient group. The company is currently conducting an extension of the study in the US (NCT05986721). In 2023, the United States held the largest market share for Mild Cognitive Impairment among the 7MM, with an estimated value of around USD 1,467 million, and this figure is projected to grow by 2034. The existing Mild Cognitive Impairment market comprises approved treatments like LEQEMBI (lecanemab) and off-label options such as cholinesterase inhibitors, memantine, and others, collectively reaching a market size of USD 222 million across the 7MM in 2023. In 2023, Japan's Mild Cognitive Impairment market was valued at approximately USD 670 million, representing around 24% of the total 7MM market, with projections indicating further growth by 2034. According to DelveInsight's analysis, the estimated number of diagnosed prevalent cases of Parkinson's disease in the US reached approximately 1.21 million in 2023. In 2023, Germany reported the highest number of diagnosed prevalent Alzheimer's disease cases among European countries, with around 1.49 million cases. France followed with approximately 1.17 million cases, while the UK had the lowest prevalence, with about 620 thousand diagnosed individuals. In Japan, around 2.73 million diagnosed cases of Mild Cognitive Impairment were recorded, with approximately 103,000 linked to Parkinson's disease and about 2.63 million associated with Alzheimer's. Forecasts indicate that by 2034, cases related to Alzheimer's will rise further, continuing to outnumber those related to Parkinson's, emphasizing the growing burden of Alzheimer's on the aging population. According to DelveInsight's analysis, the United States had the highest number of diagnosed prevalent cases of Mild Cognitive Impairment among the 7MM, with approximately 4.22 million cases reported in 2023. However, forecasts suggest that the United Kingdom is expected to surpass others and lead in diagnosed cases by 2034. Key Mild Cognitive Impairment Companies: FUJIFILM Toyama Chemical Co. Ltd., Aptinyx, AgeneBio, Eisai Inc., RespireRx, Allon Therapeutics, CuraSen Therapeutics, Inc., Avraham Pharma, AstraZeneca, Sage Therapeutics, Pfizer, Materia Medica Holding, Eli Lilly and Company, GE Healthcare, Parexel, and others Key Mild Cognitive Impairment Therapies: T-817MA, NYX-458, Aptinyx, T-817MA, Aricept (donepezil hydrochloride), CX516, AL-208, CST-2032, ladostigil hemitartrate, AZD5213, SAGE-718, fesoterodine, MMH-MAP, Donanemab, Flutemetamol (18F) Injection, EVP-0962, and others The Mild Cognitive Impairment market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Mild Cognitive Impairment pipeline products will significantly revolutionize the Mild Cognitive Impairment market dynamics. Mild Cognitive Impairment Overview Between the predicted cognitive loss associated with normal ageing and the more substantial decline associated with dementia is a period known as mild cognitive impairment (MCI). It is characterised by issues with thinking, judgement, language, and memory. Mild Cognitive Impairment Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Mild Cognitive Impairment Epidemiology Segmentation: The Mild Cognitive Impairment market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Mild Cognitive Impairment Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Mild Cognitive Impairment market or expected to get launched during the study period. The analysis covers Mild Cognitive Impairment market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Mild Cognitive Impairment Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Mild Cognitive Impairment Therapies and Key Companies LEQEMBI (lecanemab): Biogen Inc./Eisai Co., Ltd. KISUNLA (Donanemab): Eli Lilly and Company Valiltramiprosate (ALZ-801): Alzheon Inc. Mirodenafil (AR1001): AriBio Co., Ltd. Hydromethylthionine Mesylate (HMTM)/TRx0237: TauRx Therapeutics T-817MA: FUJIFILM Toyama Chemical Co. Ltd. NYX-458: Aptinyx Aptinyx: AgeneBio T-817MA: FUJIFILM Toyama Chemical Co., Ltd. Aricept (donepezil hydrochloride): Eisai Inc. CX516: RespireRx AL-208: Allon Therapeutics CST-2032: CuraSen Therapeutics, Inc. ladostigil hemitartrate: Avraham Pharma AZD5213: AstraZeneca SAGE-718: Sage Therapeutics fesoterodine: Pfizer MMH-MAP: Materia Medica Holding Donanemab: Eli Lilly and Company Flutemetamol (18F) Injection: GE Healthcare EVP-0962: Parexel Discover more about therapies set to grab major Mild Cognitive Impairment market share @ Mild Cognitive Impairment Treatment Market Scope of the Mild Cognitive Impairment Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Mild Cognitive Impairment Companies: FUJIFILM Toyama Chemical Co. Ltd., Aptinyx, AgeneBio, Eisai Inc., RespireRx, Allon Therapeutics, CuraSen Therapeutics, Inc., Avraham Pharma, AstraZeneca, Sage Therapeutics, Pfizer, Materia Medica Holding, Eli Lilly and Company, GE Healthcare, Parexel, and others Key Mild Cognitive Impairment Therapies: T-817MA, NYX-458, Aptinyx, T-817MA, Aricept (donepezil hydrochloride), CX516, AL-208, CST-2032, ladostigil hemitartrate, AZD5213, SAGE-718, fesoterodine, MMH-MAP, Donanemab, Flutemetamol (18F) Injection, EVP-0962, and others Mild Cognitive Impairment Therapeutic Assessment: Mild Cognitive Impairment current marketed and Mild Cognitive Impairment emerging therapies Mild Cognitive Impairment Market Dynamics: Mild Cognitive Impairment market drivers and Mild Cognitive Impairment market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Mild Cognitive Impairment Unmet Needs, KOL's views, Analyst's views, Mild Cognitive Impairment Market Access and Reimbursement Table of Contents 1. Mild Cognitive Impairment Market Report Introduction 2. Executive Summary for Mild Cognitive Impairment 3. SWOT analysis of Mild Cognitive Impairment 4. Mild Cognitive Impairment Patient Share (%) Overview at a Glance 5. Mild Cognitive Impairment Market Overview at a Glance 6. Mild Cognitive Impairment Disease Background and Overview 7. Mild Cognitive Impairment Epidemiology and Patient Population 8. Country-Specific Patient Population of Mild Cognitive Impairment 9. Mild Cognitive Impairment Current Treatment and Medical Practices 10. Mild Cognitive Impairment Unmet Needs 11. Mild Cognitive Impairment Emerging Therapies 12. Mild Cognitive Impairment Market Outlook 13. Country-Wise Mild Cognitive Impairment Market Analysis (2020–2034) 14. Mild Cognitive Impairment Market Access and Reimbursement of Therapies 15. Mild Cognitive Impairment Market Drivers 16. Mild Cognitive Impairment Market Barriers 17. Mild Cognitive Impairment Appendix 18. Mild Cognitive Impairment Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:

Alzheon to Present Insights into Oral Valiltramiprosate/ALZ-801 Mode of Action and Clinical Efficacy at
Alzheon to Present Insights into Oral Valiltramiprosate/ALZ-801 Mode of Action and Clinical Efficacy at

Business Wire

time15-07-2025

  • Health
  • Business Wire

Alzheon to Present Insights into Oral Valiltramiprosate/ALZ-801 Mode of Action and Clinical Efficacy at

FRAMINGHAM, Mass.--(BUSINESS WIRE)-- Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of investigational therapies and diagnostic assays for patients with Alzheimer's disease (AD) and other neurodegenerative disorders, today announced it will present new data on its lead investigational product, valiltramiprosate, highlighting the differentiated mode of action that acts upstream in the amyloid pathway, blocking formation of neurotoxic amyloid oligomers that drive disease progression. Valiltramiprosate showed positive clinical and volumetric MRI effects in patients with Mild Cognitive Impairment (MCI) who carry one or two copies of the ε4 allele of the apolipoprotein E gene (APOE3/4 heterozygotes and APOE4/4 homozygotes, respectively). The first of-its-kind data will be presented in a symposium during the Alzheimer's Association International Conference (AAIC) in Toronto, Canada. Valiltramiprosate represents a promising advancement in targeting the early highly toxic forms of beta amyloid that drive Alzheimer's disease onset and progression. Share 'Valiltramiprosate represents a promising advancement in targeting the early highly toxic forms of beta amyloid that drive Alzheimer's disease onset and progression,' said Sam Gandy, M.D., Ph.D., Professor of Neurology and Psychiatry at Icahn School of Medicine at Mount Sinai. 'By focusing on oligomer formation upstream, this oral therapy has the potential to change the treatment paradigm for patients at risk for Alzheimer's and those with early symptomatic disease, particularly the high-risk APOE4 carriers.' Valiltramiprosate is an investigational oral AD treatment in Phase 3 clinical development with an upstream mechanism of action from anti-amyloid antibodies that prevents formation of neurotoxic amyloid oligomers. A prodrug of tramiprosate with optimized pharmacokinetics and brain penetration, valiltramiprosate was designed to prevent amyloid aggregation at the initial stage of the amyloid cascade. Soluble amyloid oligomers play a central role in the pathogenesis and progression of Alzheimer's disease. 'Results from the APOLLOE4 Phase 3 trial evaluating valiltramiprosate showed promising clinical and volumetric MRI effects in Alzheimer's patients with the APOE4/4 genotype at the earliest symptomatic stage of disease. With a mechanism of action directly blocking the formation of neurotoxic beta amyloid oligomers, valiltramiprosate addresses the upstream pathology of Alzheimer's disease and offers a potential safe, effective, and accessible oral treatment,' said John Hey, PhD, Chief Scientific Officer of Alzheon. 'These findings reinforce our understanding of how valiltramiprosate works at the molecular level and provide a mechanistic foundation for the positive clinical, fluid biomarker and imaging outcomes observed in our Phase 2 and Phase 3 studies in APOE4 carriers and homozygotes, respectively, with early symptomatic AD.' Preclinical and clinical studies demonstrate that valiltramiprosate interacts with monomeric beta amyloid and prevents the formation of soluble oligomers that drive synaptic toxicity and neuronal loss. Quantitative systems pharmacology (QSP) analysis further supports the clinical relevance of this mechanism of action by linking reductions in formation of toxic amyloid oligomers to preservation of hippocampal volume, attenuation of neurodegeneration in all brain regions, and slowing of disease progression. These effects are most pronounced in the high risk APOE4/4 population, which has a high burden of neurotoxic amyloid oligomers. These clinical and biomarker results support Alzheon's precision medicine approach of focusing on high-risk APOE4 carriers with Alzheimer's disease, and provide the scientific rationale for targeting beta amyloid oligomers upstream in the disease process and at the early symptomatic stages of AD. Details of Symposium at AAIC 2025 The symposium will be held in the afternoon on July 30 th and will be available to all conference attendees, both in person at the Westin Harbor Castle in Toronto and virtually via the following link: Title: Inhibition of Beta Amyloid Oligomer Neurotoxicity with Oral Valiltramiprosate Date and Time: Wednesday, July 30, 12:30 p.m. local Toronto time (ET) Location: Westin Harbor Castle, Frontenac Ballroom Symposium Chair & Moderator: Sharon Cohen, M.D., FRCPC, Medical Director, Toronto Memory Program, Toronto, ON, Canada Presenters: Samuel Gandy, M.D., Ph.D., Professor of Neurology and Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA Kenjiro Ono, M.D., Ph.D., Department of Neuropathology, Graduate School of Medicine, Kyoto University, Kyoto, Japan Huge Geerts, M.D., Ph.D., Head of Neuroscience Modeling, Quantitative Systems Pharmacology, Certara, Berwyn, PA, USA John Hey, Ph.D., Chief Scientific Officer, Alzheon, Inc. Framingham, MA, USA In addition, Alzheon scientists will be provide clinical and imaging analyses from the APOLLOE4 Phase 3 study of valiltramiprosate in APOE4/4 homozygotes in eight poster presentations at the conference: Poster: 'Quantitative Systems Pharmacology Analysis of Hippocampal Volume Trajectory by APOE Genotype and Neuroprotective Effects of Valiltramiprosate/ALZ-801 in Early AD' Presenter: Dr. Hugo Geerts, Head of Neuroscience Modeling, Quantitative Systems Pharmacology, Certara, Berwyn, PA, USA Poster #108550 Poster: 'Efficacy and Safety of Oral Valiltramiprosate in APOE4/4 Homozygotes with Early AD: Topline Results from the APOLLOE4 Phase 3 Trial' Presenter: Dr. Aidan Power, Chief Development Officer, Alzheon, Inc. Poster #108821 Poster: 'Safety and ARIA Results of the Oral Anti-Amyloid Agent Valiltramiprosate from the Phase 3 APOLLOE4 Trial in APOE4/4 Homozygotes with Early AD' Presenter: Dr. Patrick Kesslak, Senior Research Fellow, Alzheon, Inc. Poster #108685 Poster: 'Correlations of Valiltramiprosate Effects on Hippocampal Volume and Cortical Thickness with Clinical Outcomes in the Pre-Specified MCI Group: Subgroup Analysis from the 78-Week APOLLOE4 Phase 3 Trial in APOE4/4 Homozygotes' Presenter: Dr. Susan Abushakra, Chief Medical Officer, Alzheon, Inc. Poster #108827 Poster: 'Valiltramiprosate Effects on Microstructural Integrity of Grey and White Matter in APOE4/4 Homozygotes with Early AD and their Correlations to Clinical Outcomes: MRI Mean Diffusivity Results from the 78-Week APOLLOE4 Phase 3 Trial' Presenter: Dr. Earvin Liang, Vice President of Clinical Development, Alzheon, Inc. Poster #108716 Poster: 'Quantitative Systems Pharmacology Analysis of Oral Valiltramiprosate/ALZ-801 Predicts Slowing of Alzheimer's Disease Progression by Anti-Amyloid Oligomer and APOE4 Structural Corrector Modes of Action' Presenter: Jean Schaefer, Vice President of CMC & Project Management, Alzheon, Inc. Poster #108561 Poster: 'Valiltramiprosate/ALZ-801 Prevents Hippocampal Atrophy and Clinical Decline in a Stage 2 AD Subpopulation in APOLLOE4 Phase 3 Study' Presenter: Dr. Jeremy Yu, Senior Clinical Research Fellow, Alzheon, Inc. Poster #108565 About ALZ-801 Valiltramiprosate/ALZ-801 is a potential first-in-class, investigational oral agent in Phase 3 development as a potentially disease-modifying treatment for AD. 1-5,7,10 Valiltramiprosate is designed to block the formation of neurotoxic soluble beta amyloid oligomers implicated in cognitive decline in Alzheimer's patients. 1-5,7,12 In mechanism of action studies, ALZ-801 has fully inhibited the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical trial dose. 1,7,10,12 Valiltramiprosate acts through a novel enveloping molecular mechanism of action to block formation of neurotoxic soluble amyloid oligomers in the human brain 12 associated with the onset and progression of cognitive decline in AD patients. 1,2,5,7,8 Valiltramiprosate received Fast Track designation from the U.S. Food and Drug Administration in 2017 for Alzheimer's disease. In clinical trials, valiltramiprosate has shown potential for robust clinical efficacy and favorable safety results with no increased risk of brain vasogenic edema. 3-8,11,13 The initial Phase 3 program for valiltramiprosate is focusing on Early AD patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), with potential future program expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers. 1–8 Valiltramiprosate APOLLOE4 Phase 3 Trial An Efficacy and Safety Study of Valiltramiprosate in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This trial was designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of valiltramiprosate in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer's patients. This double-blind, randomized trial compared oral valiltramiprosate to placebo treatment over 78 weeks. The APOLLOE4 trial was supported by a grant from the National Institute on Aging to Alzheon, with Susan Abushakra as the principal investigator. Valiltramiprosate APOLLOE4 Long Term Extension Trial (LTE) An ongoing long-term extension of the trial, APOLLOE4-LTE evaluates valiltramiprosate in subjects who complete the core APOLLOE4 study for an additional 104 weeks of treatment for a total of 182 weeks or 3.5 years over the core and LTE study. This LTE study is currently ongoing in the US, UK and Canada (NCT06304883). Valiltramiprosate Phase 2 Biomarker Trial Biomarker Effects of Valiltramiprosate in APOE4 Carriers with Early Alzheimer's Disease (NCT04693520): This trial was designed to evaluate the effects of 265 mg twice daily oral dose of valiltramiprosate on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer's patients. The primary outcome is the change from baseline in plasma p-tau 181. The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic profile of valiltramiprosate over 104 weeks of treatment. An ongoing long-term extension of the trial evaluates the same dose of valiltramiprosate for an additional 104 weeks of treatment for a total of 208 weeks 1,5,6. About Alzheon Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer's disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of neurodegeneration. Our lead Alzheimer's clinical candidate, valiltramiprosate/ALZ-801, is a first-in-class oral agent in Phase 3 development as a potentially disease-modifying treatment for AD. Valiltramiprosate is an oral small molecule that has been observed to fully block the formation of neurotoxic soluble amyloid oligomers in preclinical tests. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients. Alzheon Scientific Publications 1 Pearson D, et al: 2025. 2 Hey JA, et al: Clinical Pharmacokinetics of Oral ALZ-801/Valiltramiprosate in a Two-Year Phase 2 Trial of APOE4 Carriers with Early Alzheimer's Disease, Clinical Pharmacokinetics 2025. 3 Aye S, et al: Point of View: Challenges in Implementation of New Immunotherapies for Alzheimer's Disease, The Journal of Prevention of Alzheimer's Disease 2025;12(1):100022. 4 Abushakra S, et al: APOLLOE4 Phase 3 Study of Oral ALZ-801/Valiltramiprosate in APOE ε 4/ ε 4 Homozygotes with Early Alzheimer's Disease: Trial Design and Baseline Characteristics, Alzheimer's & Dementia 2024; 10(3): e12498. 5 Tolar M, et al: The Single Toxin Origin of Alzheimer's Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences 2024; 25(5), 2727. 6 Hey JA, et al: Analysis of Cerebrospinal Fluid, Plasma β Amyloid Biomarkers, and Cognition from a 2-Year Phase 2 Trial Evaluating Oral ALZ-801/Valiltramiprosate in APOE4 Carriers with Early Alzheimer's Disease Using Quantitative Systems Pharmacology Model, Drugs 2024; 84(7), 825-839. 7 Hey JA, et al: Effects of Oral ALZ-801/Valiltramiprosate on Plasma Biomarkers, Brain Hippocampal Volume, and Cognition: Results of 2-Year Single Arm, Open Label, Phase 2 Trial in APOE4 Carriers with Early Alzheimer's Disease, Drugs 2024; 84(7), 811-823. 8 Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer's Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences 2021; 22(12), 6355. 9 Abushakra S, et al: 2020; 6(1): e12117. 10 Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer's Disease with Potential for Near Term Approval, Alzheimer's Research & Therapy 2020; 12(1): 95. 11 Tolar M, et al: The Path Forward in Alzheimer's Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer's & Dementia 2020; 16(11):1553-1560. 12 Hey JA, et al: 2018; 32(9): 849-861. 13 Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer's Disease, Clinical Pharmacokinetics 2018; 57(3): 315-333. 14 Abushakra S, et al: 2017; 4(3): 149-156. 15 Kocis P, et al: 2017; 31(6): 495-509. 16 Abushakra S, et al: 2016; 3(4): 219-228.

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