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Open Peer Commentary to “Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019”
Marwan Noel Sabbagh, Jeffrey L. Cummings. Alzheimer s & Dementia, 2020-11-01
Topic: Plasma and spinal-fluid biomarkers
The results of the aducanumab studies have not been published in peer-reviewed form and both the analysis presented by Dr Knopman and collaborators and this perspective are based on data presented in 2019 at the Clinical Trials in AD (CTAD) meeting3; both discussions must be seen as tentative until full data are available. When patients in ENGAGE receiving the same exposure of those in EMERGE were analyzed, they had similar treatment outcomes on the CDR-SB suggesting that the total exposure was critical and sufficient to explain the treatment effect. Although the number of patients included in the substudies is small, there was a dose-related decrease of CSF phosphorylated tau (p-tau) and a nonsignificant trend toward diminished total tau.3 In addition, there was as significant decrease in temporal, medial temporal, and frontal composites of standard uptake value ratios (SUVR) on tau positron emission tomography (PET). Significant dose and time-related reductions in amyloid PET SUVR were demonstrated in EMERGE and ENGAGE. The observations suggest that engaging and removing insoluble amyloid plaques and ABO is followed by "downstream" effects on markers of p-tau and tau PET associated with neurofibrillary tangles. Similarly, lovastatin was the first β-Hydroxy β-methylglutaryl-CoA (HMG CoA) reductase inhibitor approved; it produced a significant mean reduction in LDL cholesterol, had few adverse effects, and was easy for patients to take.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Sabbagh, M. N., & Cummings, J. L. (2020). Open Peer Commentary to “Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019”. Alzheimer s & Dementia. https://doi.org/10.1002/alz.12235
Vancouver
Sabbagh MN, Cummings JL. Open Peer Commentary to “Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019”. Alzheimer s & Dementia. 2020. doi:10.1002/alz.12235. PMID: 33135288.
BibTeX
@article{sabbagh2020-33135288,
author = {Sabbagh, Marwan Noel and Cummings, Jeffrey L.},
title = {{Open Peer Commentary to “Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019”}},
journal = {Alzheimer s \& Dementia},
year = {2020},
doi = {10.1002/alz.12235},
pmid = {33135288},
url = {https://doi.org/10.1002/alz.12235}
}
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Key findings
- The results of the aducanumab studies have not been published in peer-reviewed form and both the analysis presented by Dr Knopman and collaborators and this perspective are based on data presented in 2019 at the Clinical Trials in AD (CTAD) meeting3; both discussions must be seen as tentative until full data are available.
- When patients in ENGAGE receiving the same exposure of those in EMERGE were analyzed, they had similar treatment outcomes on the CDR-SB suggesting that the total exposure was critical and sufficient to explain the treatment effect.
- Although the number of patients included in the substudies is small, there was a dose-related decrease of CSF phosphorylated tau (p-tau) and a nonsignificant trend toward diminished total tau.3 In addition, there was as significant decrease in temporal, medial temporal, and frontal composites of standard uptake value ratios (SUVR) on tau positron emission tomography (PET).
- Significant dose and time-related reductions in amyloid PET SUVR were demonstrated in EMERGE and ENGAGE.
- The observations suggest that engaging and removing insoluble amyloid plaques and ABO is followed by "downstream" effects on markers of p-tau and tau PET associated with neurofibrillary tangles.
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Study details
- Study designclinical trial
- Evidence strengthLow
How this study scored 41/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomized / 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, cited by studies here, still being cited, senior author's track record, institution's track record and multicenter collaboration, so those were left out: it earned 24 of the 58 points we could judge it on, which is 41 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer s & Dementia) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (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 | 2020 — within 10 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomized / blinded | 0 / 2 | No randomization 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 | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| 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 |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 33135288) |
| Free to read | 2 / 2 | Free to read |
| Points | 24 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 24 of the 58 points we could judge it on is 41 out of 100. |
| Total | 41 / 100 | — |
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