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79/100

✓ Peer-reviewed alzhub usefulness score 79 out of 100. Treatments

Topic: Amyloid, tau and blood-test diagnosis

Background A hallmark of Alzheimer's disease is the accumulation of amyloid-β (Aβ) peptide. Donanemab, an antibody that targets a modified form of deposited Aβ, is being investigated for the treatment of early Alzheimer's disease. Methods We conducted a phase 2 trial of donanemab in patients with early symptomatic Alzheimer's disease who had tau and amyloid deposition on positron-emission tomography (PET). Patients were randomly assigned in a 1:1 ratio to receive donanemab (700 mg for the first three doses and 1400 mg thereafter) or placebo intravenously every 4 weeks for up to 72 weeks. The primary outcome was the change from baseline in the score on the Integrated Alzheimer's Disease Rating Scale (iADRS; range, 0 to 144, with lower scores indicating greater cognitive and functional impairment) at 76 weeks. Secondary outcomes included the change in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), the 13-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog 13 ), the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL), and the Mini-Mental State Examination (MMSE), as well as the change in the amyloid and tau burden on PET. Results A total of 257 patients were enrolled; 131 were assigned to receive donanemab and 126 to receive placebo. The baseline iADRS score was 106 in both groups. The change from baseline in the iADRS score at 76 weeks was -6.86 with donanemab and -10.06 with placebo (difference, 3.20; 95% confidence interval, 0.12 to 6.27; P = 0.04). The results for most secondary outcomes showed no substantial difference. At 76 weeks, the reductions in the amyloid plaque level and the global tau load were 85.06 centiloids and 0.01 greater, respectively, with donanemab than with placebo. Amyloid-related cerebral edema or effusions (mostly asymptomatic) occurred with donanemab. Conclusions In patients with early Alzheimer's disease, donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed. Longer and larger trials are necessary to study the efficacy and safety of donanemab in Alzheimer's disease. (Funded by Eli Lilly; TRAILBLAZER-ALZ ClinicalTrials.gov number, NCT03367403.).

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APA 7th

Mintun, M. A., Lo, A. C., Duggan Evans, C., Wessels, A. M., Ardayfio, P. A., Andersen, S. W., et al. (2021). Donanemab in Early Alzheimer's Disease. The New England journal of medicine. https://doi.org/10.1056/nejmoa2100708

Vancouver

Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, et al. Donanemab in Early Alzheimer's Disease. The New England journal of medicine. 2021. doi:10.1056/nejmoa2100708. PMID: 33720637.

BibTeX

@article{mintun2021-33720637,
  author  = {Mintun, M. A. and Lo, A. C. and Duggan Evans, C. and Wessels, A. M. and Ardayfio, P. A. and Andersen, S. W. and Shcherbinin, S. and Sparks, J. and others},
  title   = {{Donanemab in Early Alzheimer's Disease}},
  journal = {The New England journal of medicine},
  year    = {2021},
  doi     = {10.1056/nejmoa2100708},
  pmid    = {33720637},
  url     = {https://doi.org/10.1056/nejmoa2100708}
}

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Key findings

Results A total of 257 patients were enrolled; 131 were assigned to receive donanemab and 126 to receive placebo.
The results for most secondary outcomes showed no substantial difference.
Conclusions In patients with early Alzheimer's disease, donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed.

Why it matters

In this phase 2 trial, 257 people with early symptomatic Alzheimer's disease, selected by PET scans showing amyloid and tau, were randomly assigned to donanemab or placebo infusions every 4 weeks for up to 72 weeks. At 76 weeks both groups had declined on the iADRS (0–144, lower is worse), by 6.86 points on donanemab vs 10.06 on placebo, a 3.20-point difference (95% CI 0.12 to 6.27; P = 0.04). Amyloid on PET fell 85.06 centiloids more than with placebo, but most secondary outcomes showed 'no substantial difference', brain edema or effusions (mostly asymptomatic) occurred with donanemab, and the authors, funded by Eli Lilly, say 'longer and larger trials are necessary'.

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Study details

Study designclinical trial
Participants257
Evidence strengthLow

How this study scored 79/100

Published in a top-tier journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.

Component	Points	Why
Journal tier	10 / 10	Tier 1 — top-tier general journal (The New England journal of medicine)
Journal's citation record	4 / 4	New England Journal of Medicine: journal h-index 1,505 (OpenAlex, 2026-10-29)
Study design	11 / 12	A randomised controlled trial (from PubMed type “Randomized Controlled Trial”)
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	2021 — within 6 year(s) of the newest study here
Sample size	2 / 4	257 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)
Randomised / blinded	1 / 2	Randomised (as stated in the record)
Times cited	7 / 7	Cited 1,710 times (OpenAlex, 2026-10-10)
Citations per year	5 / 5	244.3 citations a year over 7 year(s) since 2021
Impact for its field and year	6 / 6	Cited 133.1× the average for papers of its field and year (OpenAlex FWCI)
Cited by studies here	5 / 6	Cited by 156 other studies in this library
Still being cited	4 / 4	Cited 1,065 times in 2024–2026 (2026 still in progress; OpenAlex)
Senior author's track record	2 / 4	Last-listed author Daniel Skovronsky: h-index 49 (OpenAlex, whole career)
Institution's track record	1 / 3	Brown University: institution h-index 1,120 (OpenAlex)
Multi-centre collaboration	2 / 3	OpenAlex lists 5 institution(s) in 1 country
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 33720637)
Free to read	0 / 2	Behind a paywall — scores zero
Total	79 / 100	—

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