Alzheimer's disease drug development pipeline: 2017

Alzheimer's and Dementia: Translational Research and Clinical Interventions - Tập 3 Số 3 - Trang 367-384 - 2017
Jeffrey L. Cummings1, Garam Lee1, Travis Mortsdorf2, Aaron Ritter1, Kate Zhong3
1Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
2Touro University Nevada, Henderson, NV, USA
3Global Alzheimer Platform, Washington, D.C., USA

Tóm tắt

AbstractIntroductionThere is an urgent need to develop new treatments for Alzheimer's disease (AD) and to understand the drug development process for new AD therapies.MethodsWe assessed the agents in the AD pipeline as documented in clinicaltrials.gov for phase I, phase II, and phase III, accessed 1/5/2017.ResultsThere 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.DiscussionThe 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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Alzheimer's and Dementia: Translational Research and Clinical Interventions

Tập 3 Số 3

367-384

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