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Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease (S2.004)
Samantha Budd Haeberlein, Sarah Gheuens, Tianle Chen, John T. O'Gorman, Philipp von Rosenstiel, Ping Chiao, Guanfang Wang, Christian von Hehn et al.. Neurology, 2018-04-10
Topic: Drug trials: efficacy and safety
In patients treated up to 36 months, amyloid plaque levels continued to decrease in a dose- and time-dependent manner, with levels in the 10 mg/kg fixed-dose group reaching and remaining below a quantitative cut-point discriminating a positive/negative scan. 1 Reduced amyloid plaque levels were also observed in patients switched from placebo to aducanumab during the LTE. CDR–SB and MMSE data suggest clinical benefit for patients continuing aducanumab over 36 months. No new patients who continued at the same dose of aducanumab experienced ARIA-E. ARIA-E incidence at 36 months in patients switching from placebo to aducanumab was consistent with that reported on active treatment in the placebo-controlled phase. In patients from fixed-dose cohorts who completed the first two years of the LTE, amyloid plaque levels continued to decrease in a dose- and time-dependent manner and analyses of the clinical endpoints suggest a continued clinical benefit. These data support further investigation of aducanumab in the ENGAGE and EMERGE Phase 3 trials. Study Supported by: Biogen Disclosure: Dr. Budd Haeberlein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Gheuens has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Chen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. O'Gorman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Von Rosenstiel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Chiao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen; Cytel. Von Hehn has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Skordos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Hock has received personal compensation for consulting, serving on a scientific advisory board, speaking, or
Key findings
- In patients treated up to 36 months, amyloid plaque levels continued to decrease in a dose- and time-dependent manner, with levels in the 10 mg/kg fixed-dose group reaching and remaining below a quantitative cut-point discriminating a positive/negative scan. 1 Reduced amyloid plaque levels were also observed in patients switched from placebo to aducanumab during the LTE.
- CDR–SB and MMSE data suggest clinical benefit for patients continuing aducanumab over 36 months.
- No new patients who continued at the same dose of aducanumab experienced ARIA-E.
- ARIA-E incidence at 36 months in patients switching from placebo to aducanumab was consistent with that reported on active treatment in the placebo-controlled phase.
- In patients from fixed-dose cohorts who completed the first two years of the LTE, amyloid plaque levels continued to decrease in a dose- and time-dependent manner and analyses of the clinical endpoints suggest a continued clinical benefit.
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Study details
- Study designclinical trial
- Evidence strengthHigh
How this study scored 50/100
Published in a leading specialty journal. Scored zero for study design, sample size, effect reported and studied in people 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 multi-centre collaboration, so those were left out: it earned 29 of the 58 points we could judge it on, which is 50 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| 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 | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2018 — 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) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| 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 |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 29 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 29 of the 58 points we could judge it on is 50 out of 100. |
| Total | 50 / 100 | — |
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Haeberlein, S. B., Gheuens, S., Chen, T., O'Gorman, J. T., von Rosenstiel, P., Chiao, P., et al. (2018). Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease (S2.004). Neurology. https://doi.org/10.1212/wnl.90.15_supplement.s2.004
Vancouver
Haeberlein SB, Gheuens S, Chen T, O'Gorman JT, von Rosenstiel P, Chiao P, et al. Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease (S2.004). Neurology. 2018. doi:10.1212/wnl.90.15_supplement.s2.004.
BibTeX
@article{haeberlein2018-12a02583,
author = {Haeberlein, Samantha Budd and Gheuens, Sarah and Chen, Tianle and O'Gorman, John T. and von Rosenstiel, Philipp and Chiao, Ping and Wang, Guanfang and von Hehn, Christian and others},
title = {{Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease (S2.004)}},
journal = {Neurology},
year = {2018},
doi = {10.1212/wnl.90.15_supplement.s2.004},
url = {https://doi.org/10.1212/wnl.90.15_supplement.s2.004}
}
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