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Aducanumab-Related Amyloid-Related Imaging Abnormalities: Paean or Lament?
Høilund-Carlsen PF, Werner TJ, Alavi A, Revheim ME.. Clinical nuclear medicine, 2022-04-22
Topic: Brain proteins, microglia and lab models
Abstract When the FDA granted accelerated approval of Biogen's Alzheimer disease drug, aducanumab (marketed as Aduhelm), it deviated from its mission of guaranteeing drug safety and efficacy because the approval was based exclusively on a perceived dose-dependent reduction in brain amyloid deposits and not upon a proven clinical effect. We believe that the amyloid-PET scans, perceived as showing decreasing amyloid deposits, are an expression of increased cerebral cell death due to aducanumab treatment, so that with time one should instead expect a worsening and not an improvement in the treated patients' condition.
Key findings
- We believe that the amyloid-PET scans, perceived as showing decreasing amyloid deposits, are an expression of increased cerebral cell death due to aducanumab treatment, so that with time one should instead expect a worsening and not an improvement in the treated patients' condition.
Why it matters
The authors argue that the FDA's accelerated approval of aducanumab was based exclusively on a perceived dose-dependent reduction in brain amyloid deposits rather than a proven clinical effect. They believe the amyloid-PET scans may reflect increased cerebral cell death, so they expect worsening rather than improvement in treated patients.
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Study details
- Evidence strengthLow
How this study scored 35/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 34 of the 96 points we could judge it on, which is 35 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Clinical nuclear medicine) |
| Journal's citation record | 1 / 4 | Clinical Nuclear Medicine: journal h-index 90 (OpenAlex, 2026-10-29) |
| 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 | 3 / 5 | 2022 — within 6 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 | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 2 / 7 | Cited 5 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.8 citations a year over 6 year(s) since 2022 |
| Impact for its field and year | 1 / 6 | Cited 0.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 2 / 3 | University of Pennsylvania: institution h-index 1,859 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 6 institution(s) in 3 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 35452007) |
| Free to read | 2 / 2 | Free to read |
| Points | 34 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 34 of the 96 points we could judge it on is 35 out of 100. |
| Total | 35 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1097/rlu.0000000000004250
- PubMed: 35452007
- Original source →
- Free full text: Clinical Nuclear Medicine →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Høilund-Carlsen, P. F., Werner, T. J., Alavi, A., & Revheim, M. E. (2022). Aducanumab-Related Amyloid-Related Imaging Abnormalities: Paean or Lament? Clinical nuclear medicine. https://doi.org/10.1097/rlu.0000000000004250
Vancouver
Høilund-Carlsen PF, Werner TJ, Alavi A, Revheim ME. Aducanumab-Related Amyloid-Related Imaging Abnormalities: Paean or Lament? Clinical nuclear medicine. 2022. doi:10.1097/rlu.0000000000004250. PMID: 35452007.
BibTeX
@article{hoilundcarlsen2022-35452007,
author = {Høilund-Carlsen, P. F. and Werner, T. J. and Alavi, A. and Revheim, M. E.},
title = {{Aducanumab-Related Amyloid-Related Imaging Abnormalities: Paean or Lament?}},
journal = {Clinical nuclear medicine},
year = {2022},
doi = {10.1097/rlu.0000000000004250},
pmid = {35452007},
url = {https://doi.org/10.1097/rlu.0000000000004250}
}
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