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Alzheimer's disease drug development pipeline: 2017
Cummings J, Lee G, Mortsdorf T, Ritter A, Zhong K.. Alzheimer's & dementia (New York, N. Y.), 2017-05-24
Topic: Amyloid, tau and blood-test diagnosis
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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APA 7th
Cummings, J., Lee, G., Mortsdorf, T., Ritter, A., & Zhong, K. (2017). Alzheimer's disease drug development pipeline: 2017. Alzheimer's & dementia (New York, N. Y.). https://doi.org/10.1016/j.trci.2017.05.002
Vancouver
Cummings J, Lee G, Mortsdorf T, Ritter A, Zhong K. Alzheimer's disease drug development pipeline: 2017. Alzheimer's & dementia (New York, N. Y.). 2017. doi:10.1016/j.trci.2017.05.002. PMID: 29067343.
BibTeX
@article{cummings2017-29067343,
author = {Cummings, J. and Lee, G. and Mortsdorf, T. and Ritter, A. and Zhong, K.},
title = {{Alzheimer's disease drug development pipeline: 2017}},
journal = {Alzheimer's \& dementia (New York, N. Y.)},
year = {2017},
doi = {10.1016/j.trci.2017.05.002},
pmid = {29067343},
url = {https://doi.org/10.1016/j.trci.2017.05.002}
}
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Key findings
- 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.
- When compared with the 2016 pipeline, there are eight new agents in phase I, 16 in phase II, and five in phase III.
Why it matters
This report assessed the Alzheimer's disease drug development pipeline and found 105 agents in trials across phase I, phase II and phase III, with 70% being disease-modifying therapies. It describes the state of drug development and the large number of participants needed for trials, but reports no confirmed treatment, cure or prevention.
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Study details
- Participants54,073
- Evidence strengthLow
Limitations
This is a snapshot of the pipeline as it stood on a single date in 2017; drug pipelines change quickly as trials succeed, fail, or launch, so these exact figures are now out of date and should not be read as a description of the current pipeline.
How this study scored 52/100
Published in a leading specialty journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 33 of the 64 points we could judge it on, which is 52 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (New York, N. Y.)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2017 — within 10 year(s) of the newest study here |
| Sample size | 4 / 4 | 54,073 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 29067343) |
| Free to read | 2 / 2 | Free to read |
| Points | 33 / 64 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 33 of the 64 points we could judge it on is 52 out of 100. |
| Total | 52 / 100 | — |
What each of these 20 components measures, and what this score is not →
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