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Alzheimer's disease drug development pipeline: 2017
Open accessAbstract
Introduction: There is an urgent need to develop new treatments for Alzheimer's disease (AD) and to understand the drug development process for new AD therapies. Methods: We assessed the agents in the AD pipeline as documented in clinicaltrials.gov for phase I, phase II, and phase III, accessed 1/5/2017. Results: There are 105 agents in the AD treatment development pipeline, of which 25 agents are in 29 trials in phase I, 52 agents are in 68 trials in phase II, and 28 agents are in 42 trials in phase III. Seventy percent of drugs in the AD pipeline are disease‐modifying therapies (DMTs). Fourteen percent are symptomatic cognitive enhancers, and 13% are symptomatic agents addressing neuropsychiatric and behavioral changes (2% have undisclosed mechanisms). Most trials are sponsored by the biopharmaceutical industry. Trials include patients with preclinical AD (cognitively normal with biomarker evidence of AD), prodromal AD (mild cognitive symptoms and biomarker evidence of AD), and AD dementia. Biomarkers are included in many drug development programs particularly those for DMTs. Thirteen of 46 phase II DMT trials have amyloid imaging as an entry criterion, and 10 of 28 phase III trials incorporate amyloid imaging for diagnosis and entry. A large number of participants are needed for AD clinical trials; in total, 54,073 participants are required for trials spanning preclinical AD to AD dementia. When compared with the 2016 pipeline, there are eight new agents in phase I, 16 in phase II, and five in phase III. Discussion: The AD drug development pipeline has 105 agents divided among phase I, phase II, and phase III. The trials include a wide range of clinical trial populations, many mechanisms of action, and require a substantial number of clinical trial participants. Biomarkers are increasingly used in patient identification and as outcome measures, particularly in trials of DMTs.
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“A number of additional pathogenic mechanisms have been described, possibly overlapping with Aβ plaques and NFT formation or induced by them, including inflammation, oxidative damage, iron deregulation, and cholesterol metabolism blood-brain barrier (BBB) dysfunction or α-synuclein toxicity.9-13”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [12]
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Metadata
- Authors
- Cummings, J., Lee, G., Mortsdorf, T., Ritter, A., & Zhong, K.
- Affiliations
- Cleveland Clinic (US)
- Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas NV USA
- Touro University Nevada Henderson NV USA
- Corresponding author
- Cummings, Jeffrey
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2017-05-24
- Volume
- 3
- Issue
- 3
- Pages
- 367-384
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC5651419
- OpenAlex
- W2617072792
- Cited by
- 549
- References
- 47
- Citations by year
- 2026: 14 · 2025: 53 · 2024: 48 · 2023: 52 · 2022: 67 · 2021: 59 · 2020: 53 · 2019: 91 · 2018: 103 · 2017: 7
- FWCI
- 52.02
- 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)
- Digital Scholarship - UNLV (University of Nevada Reno) (submittedVersion, cc-by-nc)
- Funders
- National Institute on Aging (R01AG084250 R56AG074001 U01AG073323 R01AG066707 R01AG076448 R01AG082118 RF1AG082211 R21AG083003 R35AG71476)
- National Institute of General Medical Sciences (NIA R25AG083721, NIA R35AG71476, P20GM109025)
- National Institute of Neurological Disorders and Stroke (RF1NS133812)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Keywords
- Alzheimer's disease, drug development pipeline, clinical trials, disease-modifying therapy, prodromal Alzheimer's disease, preclinical Alzheimer's disease, amyloid imaging, biomarkers, clinical trial participants
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