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      Alzheimer's disease drug development pipeline: 2022

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          Abstract

          Introduction

          Alzheimer's disease (AD) represents a global health crisis. Treatments are needed to prevent, delay the onset, slow the progression, improve cognition, and reduce behavioral disturbances of AD. We review the current clinical trials and drugs in development for the treatment of AD.

          Methods

          We searched the governmental website clinicaltrials.gov where are all clinical trials conducted in the United States must be registered. We used artificial intelligence (AI) and machine learning (ML) approaches to ensure comprehensive detection and characterization of trials and drugs in development. We use the Common Alzheimer's Disease Research Ontology (CADRO) to classify drug targets and mechanisms of action of drugs in the pipeline.

          Results

          As of January 25, 2022 (index date for this study) there were 143 agents in 172 clinical trials for AD. The pipeline included 31 agents in 47 trials in Phase 3, 82 agents in 94 trials in Phase 2, and 30 agents in 31 trials in Phase 1. Disease‐modifying therapies represent 83.2% of the total number of agents in trials; symptomatic cognitive enhancing treatments represent 9.8% of agents in trials; and drugs for the treatment of neuropsychiatric symptoms comprise 6.9%. There is a diverse array of drug targets represented by agents in trials including nearly all CADRO categories. Thirty‐seven percent of the candidate agents in the pipeline are repurposed drugs approved for other indications. A total of 50,575 participants are needed to fulfill recruitment requirements for all currently active clinical trials.

          Discussion

          The AD drug development pipeline has agents representing a substantial array of treatment mechanisms and targets. Advances in drug design, outcome measures, use of biomarkers, and trial conduct promise to accelerate the delivery of new and better treatments for patients with AD.

          Highlights

          • There are 143 drugs in the current Alzheimer's disease (AD) drug development pipeline.

          • Disease‐modifying therapies represent 83.2% of the candidate treatments.

          • Current trials require 50,575 participants who will donate 3,878,843 participant‐weeks to clinical trials.

          • The biopharmaceutical industry sponsors 50% of all clinical trials including 68% of Phase 3 trials.

          • Sixty‐three percent of Phase 3 trials and 46% of Phase 2 trials include non–North American clinical trial site locations indicating the global ecosystem required for AD drug development.

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          Most cited references41

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          Alzheimer's disease

          In this Seminar, we highlight the main developments in the field of Alzheimer's disease. The most recent data indicate that, by 2050, the prevalence of dementia will double in Europe and triple worldwide, and that estimate is 3 times higher when based on a biological (rather than clinical) definition of Alzheimer's disease. The earliest phase of Alzheimer's disease (cellular phase) happens in parallel with accumulating amyloid β, inducing the spread of tau pathology. The risk of Alzheimer's disease is 60-80% dependent on heritable factors, with more than 40 Alzheimer's disease-associated genetic risk loci already identified, of which the APOE alleles have the strongest association with the disease. Novel biomarkers include PET scans and plasma assays for amyloid β and phosphorylated tau, which show great promise for clinical and research use. Multidomain lifestyle-based prevention trials suggest cognitive benefits in participants with increased risk of dementia. Lifestyle factors do not directly affect Alzheimer's disease pathology, but can still contribute to a positive outcome in individuals with Alzheimer's disease. Promising pharmacological treatments are poised at advanced stages of clinical trials and include anti-amyloid β, anti-tau, and anti-inflammatory strategies.
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            2021 Alzheimer's disease facts and figures

            (2021)
            This article describes the public health impact of Alzheimer's disease (AD), including incidence and prevalence, mortality and morbidity, use and costs of care, and the overall impact on caregivers and society. The Special Report discusses the challenges of providing equitable health care for people with dementia in the United States. An estimated 6.2 million Americans age 65 and older are living with Alzheimer's dementia today. This number could grow to 13.8 million by 2060 barring the development of medical breakthroughs to prevent, slow or cure AD. Official death certificates recorded 121,499 deaths from AD in 2019, the latest year for which data are available, making Alzheimer's the sixth-leading cause of death in the United States and the fifth-leading cause of death among Americans age 65 and older. Between 2000 and 2019, deaths from stroke, heart disease and HIV decreased, whereas reported deaths from AD increased more than 145%. This trajectory of deaths from AD was likely exacerbated in 2020 by the COVID-19 pandemic. More than 11 million family members and other unpaid caregivers provided an estimated 15.3 billion hours of care to people with Alzheimer's or other dementias in 2020. These figures reflect a decline in the number of caregivers compared with a decade earlier, as well as an increase in the amount of care provided by each remaining caregiver. Unpaid dementia caregiving was valued at $256.7 billion in 2020. Its costs, however, extend to family caregivers' increased risk for emotional distress and negative mental and physical health outcomes - costs that have been aggravated by COVID-19. Average per-person Medicare payments for services to beneficiaries age 65 and older with AD or other dementias are more than three times as great as payments for beneficiaries without these conditions, and Medicaid payments are more than 23 times as great. Total payments in 2021 for health care, long-term care and hospice services for people age 65 and older with dementia are estimated to be $355 billion. Despite years of efforts to make health care more equitable in the United States, racial and ethnic disparities remain - both in terms of health disparities, which involve differences in the burden of illness, and health care disparities, which involve differences in the ability to use health care services. Blacks, Hispanics, Asian Americans and Native Americans continue to have a higher burden of illness and lower access to health care compared with Whites. Such disparities, which have become more apparent during COVID-19, extend to dementia care. Surveys commissioned by the Alzheimer's Association recently shed new light on the role of discrimination in dementia care, the varying levels of trust between racial and ethnic groups in medical research, and the differences between groups in their levels of concern about and awareness of Alzheimer's disease. These findings emphasize the need to increase racial and ethnic diversity in both the dementia care workforce and in Alzheimer's clinical trials.
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              Donanemab in Early Alzheimer’s Disease

              A hallmark of Alzheimer's disease is the accumulation of amyloid-β (Aβ) peptide. Donanemab, an antibody that targets a modified form of deposited Aβ, is being investigated for the treatment of early Alzheimer's disease.
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                Author and article information

                Contributors
                jcummings@cnsinnovations.com
                Journal
                Alzheimers Dement (N Y)
                Alzheimers Dement (N Y)
                10.1002/(ISSN)2352-8737
                TRC2
                Alzheimer's & Dementia : Translational Research & Clinical Interventions
                John Wiley and Sons Inc. (Hoboken )
                2352-8737
                04 May 2022
                2022
                : 8
                : 1 ( doiID: 10.1002/trc2.v8.1 )
                : e12295
                Affiliations
                [ 1 ] Chambers‐Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences University of Nevada, Las Vegas (UNLV) Henderson Nevada USA
                [ 2 ] Department of Brain Health, School of Integrated Health Sciences University of Nevada, Las Vegas (UNLV) Henderson Nevada USA
                [ 3 ] Biogen Weston Massachusetts USA
                [ 4 ] Howard R. Hughes College of Engineering Department of Computer Science University of Nevada, Las Vegas (UNLV) Henderson Nevada USA
                Author notes
                [*] [* ] Correspondence

                Jeffrey Cummings, Chambers‐Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas (UNLV), 1380 Opal Valley Street, Henderson, NV 89052, USA

                E‐mail: jcummings@ 123456cnsinnovations.com

                Article
                TRC212295
                10.1002/trc2.12295
                9066743
                35516416
                78e7aebd-9e57-4bbb-aa1c-09b9dc4a99eb
                © 2022 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 16 March 2022
                : 15 March 2022
                : 17 March 2022
                Page count
                Figures: 4, Tables: 8, Pages: 24, Words: 12058
                Funding
                Funded by: NIGMS , doi 10.13039/100000057;
                Award ID: P20GM109025
                Funded by: NINDS , doi 10.13039/100000065;
                Award ID: U01NS093334
                Funded by: NIA , doi 10.13039/100000049;
                Award ID: R01AG053798
                Award ID: P20AG068053
                Award ID: R35AG71476
                Funded by: Alzheimer's Disease Drug Discovery Foundation (ADDF)
                Categories
                Review Article
                Review Articles
                Custom metadata
                2.0
                2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.4 mode:remove_FC converted:04.05.2022

                aducanumab,alzheimer's disease,amyloid,biomarkers,clinical trials,common alzheimer's disease research ontology (cadro),donanemab,drug development,inflammation,lecanemab,pharmaceutical companies,repurposed drugs,tau

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