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Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease
S Cohen, C H van Dyck, M Gee, T Doherty, M Kanekiyo, S Dhadda, D Li, S Hersch et al.. The journal of prevention of Alzheimer's disease, 2023
Topic: Drug trials: efficacy and safety
Plain-language summary
A total of 1795 participants were enrolled (lecanemab:898; placebo:897). At month 18, adjusted mean change from baseline in EQ-5D-5L and QOL-AD by subject showed 49% and 56% less decline, respectively. QOL-AD rated by study partner as proxy resulted in 23% less decline. ZBI adjusted mean change from baseline at 18 months resulted in 38% less increase of care partner burden. Individual HRQoL test items and dimensions also showed lecanemab benefit. Lecanemab was associated with a relative preservation of HRQoL and less increase in caregiver burden, with consistent benefits seen across different quality of life scales and within scale subdomains. These benefits provide valuable patient reported outcomes which, together with previously reported benefits of lecanemab across multiple measures of cognition, function, disease progression, and biomarkers, demonstrate that lecanemab treatment may offer meaningful benefits to patients, care partners, and society.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Cohen, S., van Dyck, C. H., Gee, M., Doherty, T., Kanekiyo, M., Dhadda, S., et al. (2023). Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease. The journal of prevention of Alzheimer's disease. https://doi.org/10.14283/jpad.2023.123
Vancouver
Cohen S, van Dyck CH, Gee M, Doherty T, Kanekiyo M, Dhadda S, et al. Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease. The journal of prevention of Alzheimer's disease. 2023. doi:10.14283/jpad.2023.123. PMID: 37874099.
BibTeX
@article{cohen2023-37874099,
author = {Cohen, S and van Dyck, C H and Gee, M and Doherty, T and Kanekiyo, M and Dhadda, S and Li, D and Hersch, S and others},
title = {{Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease}},
journal = {The journal of prevention of Alzheimer's disease},
year = {2023},
doi = {10.14283/jpad.2023.123},
pmid = {37874099},
url = {https://doi.org/10.14283/jpad.2023.123}
}
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Key findings
- A total of 1795 participants were enrolled (lecanemab:898; placebo:897).
- At month 18, adjusted mean change from baseline in EQ-5D-5L and QOL-AD by subject showed 49% and 56% less decline, respectively.
- QOL-AD rated by study partner as proxy resulted in 23% less decline.
- ZBI adjusted mean change from baseline at 18 months resulted in 38% less increase of care partner burden.
- Individual HRQoL test items and dimensions also showed lecanemab benefit.
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Study details
- Study designclinical trial
- Participants1,795
- Evidence strengthLow
How this study scored 75/100
Published in a peer-reviewed journal, and it is a large phase 3 trial. Scored zero for effect reported 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, multicenter collaboration and free to read, so those were left out: it earned 42 of the 56 points we could judge it on, which is 75 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of prevention of Alzheimer's disease) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A large phase 3 trial (from PubMed type “Clinical Trial, Phase III”) |
| 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 | 3 / 4 | 1,795 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) |
| Randomized / blinded | 2 / 2 | Randomized 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 |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37874099) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 42 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 42 of the 56 points we could judge it on is 75 out of 100. |
| Total | 75 / 100 | — |
What each of these 20 components measures, and what this score is not →
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