Alzheimer’s disease drug development pipeline: 2020
Open accessAbstract
INTRODUCTION: Alzheimer's disease (AD) is a growing public health concern affecting millions of patients worldwide and costing billions of dollars annually. We review the pipeline of drugs and biologics in clinical trials for the treatment of AD. We use the Common Alzheimer's and Related Dementias Research Ontology (CADRO) to classify treatment targets and mechanisms of action. We review our annual pipeline reports for the past 5 years to provide longitudinal insight into clinical trials and drug development for AD. METHODS: We reviewed ClinicalTrials.gov as of February 27, 2020, and identified all trials of pharmacologic agents currently being developed for treatment of AD as represented on this widely used U.S. Food and Drug Administration registry. RESULTS: There are 121 agents in clinical trials for the treatment of AD. Twenty-nine agents are in 36 Phase 3 trials, 65 agents are in 73 Phase 2 trials, and 27 agents are in 27 Phase 1 trials. Twelve agents in trials target cognitive enhancement and 12 are intended to treat neuropsychiatric and behavioral symptoms. There are 97 agents in disease modification trials. Compared to the 2019 pipeline, there is an increase in the number of disease-modifying agents targeting pathways other than amyloid or tau. DISCUSSION: The 2020 pipeline has innovations in clinical trials and treatment targets that provide hope for greater success in AD drug development programs. Review of clinical trials over the past 5 years show that there is progressive emphasis on non-amyloid targets, including candidate treatments for inflammation, synapse and neuronal protection, vascular factors, neurogenesis, and epigenetic interventions. There has been a marked growth in repurposed agents in the pipeline.
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High failure rate and limited drug development reflect biological disconnect and restricted translatability between mouse models and human pathology.
“The high failure rate of agents in clinical trials and relatively limited drug development for AD reflect the biological disconnect and thus restricted translatability between mouse models and human pathology.”
From Microglia and monocytes in inflammatory CNS disease: integrating phenotype and function (2022) · cites this paper as [68]
The Discussion (page not provided) reports relatively few AD drugs in development and a high risk of failure. It attributes the development disparity to poorly defined target biology, limited biomarkers, longer trials, and greater expense; it does not attribute trial failures or limited development to a biological disconnect between mouse models and human pathology. (LLM, conf=0.86)
Experimental — accuracy not yet measuredLimited availability of human biomarkers, longer trial durations, and high trial costs exacerbate the disconnect.
“This is further exacerbated by the limited availability of human biomarkers, longer trial durations and prohibitively high trial costs [68, 86, 102]”
From Microglia and monocytes in inflammatory CNS disease: integrating phenotype and function (2022) · cites this paper as [68]
In 2020, there was ~40-fold and ~threefold decrease in number of drugs in development for AD compared to malignant neoplasms and diabetes.
“In 2020, there was ~ 40-fold and ~ threefold decrease, respectively, in the number of drugs in development for AD, compared to those in development for malignant neoplasms and diabetes [68]”
From Microglia and monocytes in inflammatory CNS disease: integrating phenotype and function (2022) · 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 [70]
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 [70]
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- Authors
- Cummings, J., Lee, G., Ritter, A., Sabbagh, M., & Zhong, K.
- Affiliations
- Cleveland Clinic (US)
- CNS Innovations Henderson Nevada USA
- Corresponding author
- Cummings, Jeffrey
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2020-01
- Volume
- 6
- Issue
- 1
- Pages
- e12050-e12050
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC7364858
- OpenAlex
- W3043145818
- Cited by
- 557
- References
- 49
- Citations by year
- 2026: 26 · 2025: 41 · 2024: 56 · 2023: 56 · 2022: 160 · 2021: 186 · 2020: 32
- FWCI
- 65.70
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institute of General Medical Sciences (P20GM109025)
- 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, amyloid, tau protein, cognitive enhancement, neuropsychiatric symptoms, repurposed drugs, inflammation, vascular factors, neurogenesis, epigenetic interventions, treatment goals
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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