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The study has read out. The evidence is not finished.

Gain a deeper understanding of your completed study by contextualizing the population, endpoints, and variability, and turn those insights into better-informed clinical development decisions.

Evidence for a smaller, faster Phase 3 in Alzheimer's

AbbVie applied Unlearn's digital twins to their completed Phase 2 AWARE study (NCT02880956), a randomized, double-blind, placebo-controlled trial in early AD assessing CDR-SB at Week 96. Result: a 17% sample-size reduction with 90% power maintained, without compromising Type-1 error control.In Alzheimer's program planning, retrospective analyses project Phase 3 savings of ~$50M–$70M and 4–5+ months per program.

~$50M - $70M
phase 3 savings

This variance reduction (with digital twins) could have had a significant impact on the number of subjects we needed…and still preserved the same power…we would have had a faster enrollment, encourage(d) greater patient participation. And ultimately, that would have been cost saving and time saving.

Ole Graff, AbbVie, Presentation at AD/PD 2025 Conference

Readout informs the next design.

What this study revealed becomes evidence for the decision that follows readout, whether and how the program continues: a validated view of disease progression, a better estimate of the effect, and a design that starts from what you now know.

Reach out to us about where your study is today.