Comparing clinical effect sizes of Souvenaid TM,lecanemab,and donanemab in early Alzheimer’s disease

Abstract

Background

Lecanemab 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 (Souvenaid^TM), a multi-nutrient intervention, has shown potential clinical benefits in prodromal AD.

Objective

To 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.

Methods

Cohen'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.

Results

Point 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™.

Conclusions

Despite differences in study designs, Souvenaid^TM demonstrated comparable clinical efficacy with superior safety, accessibility, and cost profile. These findings support further evaluation of Souvenaid^TM as a non-invasive, scalable option in early AD management.