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Comparing clinical effect sizes of SouvenaidTM, lecanemab, and donanemab in early Alzheimer's disease
Vincenzo Solfrizzi, Bruno P Imbimbo. Journal of Alzheimer's disease : JAD, 2025-12-22
Topic: Drug trials: efficacy and safety
BackgroundLecanemab and donanemab are anti-amyloid-β monoclonal antibodies recently approved in the United States and Europe for the treatment of early Alzheimer's disease (AD). Their modest clinical benefit, safety profile, and cost raise debate about real-world applicability. Fortasyn Connect (SouvenaidTM), a multi-nutrient intervention, has shown potential clinical benefits in prodromal AD.ObjectiveTo compare the clinical effect sizes (Cohen's d) and estimated months of preserved independence in instrumental activities of daily living (IADLs) for lecanemab, donanemab, and Souvenaid™, based on published pivotal clinical trial data.MethodsCohen's d on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) was computed using standardized mean differences and 95% confidence intervals (CIs) derived from published trials. Times of functional independence were estimated using the Hartz approach.ResultsPoint estimates of Cohen's d effect sizes on CDR-SB were -0.34, -0.33, and -0.52 for lecanemab, donanemab, and Souvenaid™, respectively, with no statistically significant differences between drugs. Estimated gains in IADL independence were 10 months for lecanemab, 8 months for donanemab, and 27 months for Souvenaid™.ConclusionsDespite differences in study designs, SouvenaidTM demonstrated comparable clinical efficacy with superior safety, accessibility, and cost profile. These findings support further evaluation of SouvenaidTM as a non-invasive, scalable option in early AD management.
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APA 7th
Solfrizzi, V., & Imbimbo, B. P. (2026). Comparing clinical effect sizes of SouvenaidTM, lecanemab, and donanemab in early Alzheimer's disease. Journal of Alzheimer's disease : JAD. https://doi.org/10.1177/13872877251406221
Vancouver
Solfrizzi V, Imbimbo BP. Comparing clinical effect sizes of SouvenaidTM, lecanemab, and donanemab in early Alzheimer's disease. Journal of Alzheimer's disease : JAD. 2026. doi:10.1177/13872877251406221. PMID: 41428477.
BibTeX
@article{solfrizzi2026-41428477,
author = {Solfrizzi, Vincenzo and Imbimbo, Bruno P},
title = {{Comparing clinical effect sizes of SouvenaidTM, lecanemab, and donanemab in early Alzheimer's disease}},
journal = {Journal of Alzheimer's disease : JAD},
year = {2026},
doi = {10.1177/13872877251406221},
pmid = {41428477},
url = {https://doi.org/10.1177/13872877251406221}
}
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Key findings
- Times of functional independence were estimated using the Hartz approach.ResultsPoint estimates of Cohen's d effect sizes on CDR-SB were -0.34, -0.33, and -0.52 for lecanemab, donanemab, and Souvenaid™, respectively, with no statistically significant differences between drugs.
- Estimated gains in IADL independence were 10 months for lecanemab, 8 months for donanemab, and 27 months for Souvenaid™.ConclusionsDespite differences in study designs, SouvenaidTM demonstrated comparable clinical efficacy with superior safety, accessibility, and cost profile.
- These findings support further evaluation of SouvenaidTM as a non-invasive, scalable option in early AD management.
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Study details
- Evidence strengthLow
How this study scored 45/100
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, multi-centre collaboration and free to read, so those were left out: it earned 25 of the 56 points we could judge it on, which is 45 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Alzheimer's disease : JAD) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| 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 | 5 / 5 | 2026 — within 1 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 41428477) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 25 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 25 of the 56 points we could judge it on is 45 out of 100. |
| Total | 45 / 100 | — |
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