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Cited by 665Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative Diseases

Alzheimer’s disease drug development pipeline: 2022

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Cummings, Jeffrey, Lee, Garam, Nahed, Pouyan, Kambar, Mina Esmail Zadeh Nojoo, Zhong, Kate, Fonseca, Jorge, Taghva, Kazem·2022·Alzheimer's & Dementia: Translational Research & Clinical Interventions
DOI 10.1002/trc2.12295PMC PMC9066743
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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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  • Clinical trials have investigated disease-modifying therapies (DMTs) intended to affect AD pathological processes by targeting amyloidβ or tau protein, inflammatory pathways, or metabolic dysfunction, as they may alter illness expression and progression.

    “Clinical trials have investigated disease-modifying therapies (DMTs), drugs intended to affect AD pathological processes by targeting amyloidβ (Abeta) or tau protein, inflammatory pathways, or metabolic dysfunction,(496) as they may alter illness expression and progression.”

    From Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission (2024) · cites this paper as [496]

  • The primary goal of DMTs for AD patients is to slow the rate of cognitive decline.

    “The primary goal of DMTs for AD patients is to slow the rate of cognitive decline [66,67,68].”

    From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [68]

  • Of these trials, 41% look into disease-modifying small molecule medications, 34% look into biological agents that change disease, and the remaining trials focus on treatments that improve cognitive function or address neuropsychiatric symptoms linked to AD.

    “Of these trials, 41% look into disease-modifying small molecule medications, 34% look into biological agents that change disease, and the remaining trials focus on treatments that improve cognitive function or address neuropsychiatric symptoms linked to ADs [68,70,71,182,183,184].”

    From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [68]

  • The 2024 AD drug development pipeline includes 164 trials, of which 127 are exploring possible treatments or medicines.

    “The most recent list of studies was provided by the 2024 AD drug development pipeline, which includes 164 trials (of which 127 are exploring possible treatments or medicines).”

    From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [68]

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Research works printed but not linked: 2

  1. [17]Kambar MEZN, Nahed P, Cacho JRF, et al. Clinical text classification of Alzheimer's drugs’ mechanism of action In: Yang XS., Sherratt S., Dey N., Joshi A. (eds) Proceedings of Sixth International Congress on Information and Communication Technology. Lecture Notes in Networks and Systems, vol 235. Springer, Singapore. 10.1007/978-981-16-2377-6_48.2022. · DOI
  2. [32]Food and Drug Administration. Conduct of Clinical Trials of Medical Products during the COVID‐19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards. Food and Drug Administration; 2020. Updated on August 30, 2021. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) Oncology Center of Excellence (OCE), Office of Good Clinical Practice (OGCP). Washington, DC: Food and Drug Administration; 2020. Updated August 2021. 2021.

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Authors
Cummings, J., Lee, G., Nahed, P., Kambar, M. E. Z. N., Zhong, K., Fonseca, J., & Taghva, K.
Affiliations
  • University of Nevada, Las Vegas (US)
  • Biogen (United States) (US)
  • Howard R. Hughes College of Engineering Department of Computer Science University of Nevada, Las Vegas (UNLV) Henderson Nevada USA
Corresponding author
Cummings, Jeffrey
ORCID
Venue
Alzheimer's & Dementia: Translational Research & Clinical Interventions
Publisher
Wiley
Published
2022-01
Volume
8
Issue
1
Pages
e12295-e12295
ISSN
2352-8737 (ISSN-L)
DOI
10.1002/trc2.12295
PMC
PMC9066743
OpenAlex
W4285132881
Cited by
665
References
40
Citations by year
2026: 46 · 2025: 116 · 2024: 182 · 2023: 228 · 2022: 77 · 2021: 11 · 2020: 3 · 2018: 2
FWCI
20.80
Type
journal article
Language
en
Open access
Licence
Locations
  • Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Digital Scholarship - UNLV (University of Nevada Reno) (submittedVersion, cc-by-nc-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
  • National Institute of General Medical Sciences (P20GM109025)
  • National Institute of Neurological Disorders and Stroke (U01NS093334)
  • National Institute on Aging (R01AG053798, P20AG068053, R35AG71476)
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
Keywords
Alzheimer's disease, drug development pipeline, clinical trials, disease-modifying therapy, symptomatic treatment, neuropsychiatric symptoms, drug repurposing, therapeutic target, mechanism of action, clinical trial recruitment, clinical trial sites

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