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Assessing preparedness for Alzheimer disease‐modifying therapies in Australasian health care systems
Amy G. Brodtmann, David Darby, Carly Oboudiyat, Colin Mahoney, Campbell J. Le Heron, Peter K. Panegyres, Bruce J. Brew. The Medical Journal of Australia, 2023-03-19
Topic: Drug trials: efficacy and safety
Three deaths have been reported related to treatment with lecanemab.6 Patients receiving DMT require frequent monitoring with MRI brain scans (four or more per year), as there is a high rate of clinically significant amyloid-related imaging abnormalities (ARIA), both brain oedema (ARIA-E) and macro- and microhaemorrhages (ARIA-H). Although most cases of ARIA are asymptomatic, close monitoring with MRI is mandated.7 So far, these therapies have been associated with increased brain volume loss (ie, increased brain atrophy). It is fortunate that a multidisciplinary team model is accepted practice in dementia care,15 but dementia care delivery models will require significant modification. Furthermore, abnormal biomarkers alone raise significant management issues, including treatment of asymptomatic patients (amyloid not causing cognitive decline) and of patients excluded from trials (eg, those with multiple microhaemorrhages). Conservative estimates of demand for an intravenous Alzheimer disease treatment would represent a fivefold increase in patients compared with multiple sclerosis. Other Alzheimer disease DMTs are in phase 3 trials, with results of further phase 3 trials expected at the end of 2023 (eg, ClinicalTrials.gov NCT04437511, NCT04388254, and NCT04592874).
Key findings
- Three deaths have been reported related to treatment with lecanemab.6 Patients receiving DMT require frequent monitoring with MRI brain scans (four or more per year), as there is a high rate of clinically significant amyloid-related imaging abnormalities (ARIA), both brain oedema (ARIA-E) and macro- and microhaemorrhages (ARIA-H).
- Although most cases of ARIA are asymptomatic, close monitoring with MRI is mandated.7 So far, these therapies have been associated with increased brain volume loss (ie, increased brain atrophy).
- It is fortunate that a multidisciplinary team model is accepted practice in dementia care,15 but dementia care delivery models will require significant modification.
- Furthermore, abnormal biomarkers alone raise significant management issues, including treatment of asymptomatic patients (amyloid not causing cognitive decline) and of patients excluded from trials (eg, those with multiple microhaemorrhages).
- Conservative estimates of demand for an intravenous Alzheimer disease treatment would represent a fivefold increase in patients compared with multiple sclerosis.
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Study details
- Study designclinical trial
- Evidence strengthLow
How this study scored 43/100
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 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 25 of the 58 points we could judge it on, which is 43 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The Medical Journal of Australia) |
| 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 | 3 / 5 | 2023 — 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 | — / 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 | 2 / 2 | Indexed in PubMed (PMID 36934371) |
| Free to read | 2 / 2 | Free to read |
| Points | 25 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 25 of the 58 points we could judge it on is 43 out of 100. |
| Total | 43 / 100 | — |
What each of these 20 components measures, and what this score is not →
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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. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Brodtmann, A. G., Darby, D., Oboudiyat, C., Mahoney, C., Le Heron, C. J., Panegyres, P. K., et al. (2023). Assessing preparedness for Alzheimer disease‐modifying therapies in Australasian health care systems. The Medical Journal of Australia. https://doi.org/10.5694/mja2.51880
Vancouver
Brodtmann AG, Darby D, Oboudiyat C, Mahoney C, Le Heron CJ, Panegyres PK, et al. Assessing preparedness for Alzheimer disease‐modifying therapies in Australasian health care systems. The Medical Journal of Australia. 2023. doi:10.5694/mja2.51880. PMID: 36934371.
BibTeX
@article{brodtmann2023-36934371,
author = {Brodtmann, Amy G. and Darby, David and Oboudiyat, Carly and Mahoney, Colin and Le Heron, Campbell J. and Panegyres, Peter K. and Brew, Bruce J.},
title = {{Assessing preparedness for Alzheimer disease‐modifying therapies in Australasian health care systems}},
journal = {The Medical Journal of Australia},
year = {2023},
doi = {10.5694/mja2.51880},
pmid = {36934371},
url = {https://doi.org/10.5694/mja2.51880}
}
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