CDR-SB (Clinical Dementia Rating - Sum of Boxes)
Neurology· appears in 340+ cited findings in this library
What it is and how the reviews use it
The Clinical Dementia Rating - Sum of Boxes (CDR-SB) is an endpoint used in regulatory review documents to assess the severity of dementia. The CDR-SB score ranges from 0 to 18, as noted in the EISAI INC — Leqembi FDA Review (NDA/BLA 761269, 2024) and Eli Lilly and Company — Kisunla FDA Review (BLA761248, ORIG 1, 2024) documents. It is used to quantify changes in cognitive and functional abilities over time.
Regulatory reviews in this library frequently utilize CDR-SB to evaluate treatment effects. For example, the EISAI INC — Leqembi FDA Summary Review (NDA/BLA 761269, 2023) reported that 95% of the treatment effect on CDR-SB (10 mg/kg biweekly) was explained by amyloid PET SUVR. In the Eli Lilly and Company — Kisunla FDA Review (BLA761248, ORIG 1, 2024), the CDR-SB treatment effect for the combined population was -0.70 [-29%]. CervoMed Inc. also reported a CDR-SB change from baseline of 0.70 points in an SEC 8-K (2026-08-10) filing.
Real examples — cited to the source page
| Leqembi | Proportion of treatment effect on CDR-SB explained by amyloid PET SUVR (10 mg/kg biweekly) | 95 | EISAI INC — Leqembi FDA Summary Review, p.28 |
| Kisunla | CDR-SB treatment effect (combined population) | -0.70 [-29%] | Eli Lilly and Company — Kisunla FDA Review, p.11 |
| CervoMed Inc. | CDR-SB change from baseline | 0.70 | CervoMed Inc. — SEC 8-K (2026-08-10), p.2 |
| Leqembi | Change from baseline in CDR-SB | -0.40 | EISAI INC — Leqembi FDA Review, p.38 |
| Kisunla | CDR-SB change from baseline (donanemab vs placebo) | -0.51 | Eli Lilly and Company — Kisunla EMA EPAR public assessment report, p.66 |
| CervoMed Inc. | Average DP Batch B-Placebo CDR-SB Difference | -1.11 | CervoMed Inc. — SEC 8-K (2026-03-19), p.2 |
| Cyclerion Therapeutics, Inc. | CDR-SB slowing | ~30% | Cyclerion Therapeutics, Inc. — SEC 8-K (2026-04-01), p.5 |
| Inmune Bio, Inc. | Correlation between cognitive composites and CDR-SB | 0.65 | Inmune Bio, Inc. — SEC 8-K (2026-02-27), p.36 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
Explore the full evidence
Every CDR-SB finding in the library — searchable and answerable in plain language — is in the Neurology research library →
Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.