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ADAS-Cog

Neurologyยท appears in 215+ cited findings in this library

What it is and how the reviews use it

The ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) is a widely used endpoint in regulatory reviews for treatments targeting Alzheimer's disease. It measures cognitive function, with different versions having varying score ranges. The ADAS-Cog 13 has a score range from 0 to 85, as noted in the Eli Lilly and Company โ€” Kisunla FDA Review (BLA761248, ORIG 1, 2024), while the ADAS-cog has a score range of 0 to 70 according to the SANDOZ โ€” Exelon FDA Review (NDA/BLA 022083, 2016). The ADAS-Cog 14 scale has a range from 0 to 90, as seen in the EISAI INC โ€” Leqembi FDA Review (NDA/BLA 761269, 2024).

Regulatory reviews in this library frequently use ADAS-Cog to assess treatment effects on cognitive decline. For instance, the Eli Lilly and Company โ€” Kisunla FDA Review (BLA761248, ORIG 1, 2024) reported an ADAS-Cog 13 treatment effect of -1.33 [-20%]. In the SANDOZ โ€” Exelon FDA Review (NDA/BLA 022083, 2016), the ADAS-cog treatment difference was -1.47. The EISAI INC โ€” Leqembi FDA Review (NDA/BLA 761269, 2024) noted a change from baseline in ADAS-Cog14 of -2.31.

Real examples โ€” cited to the source page

COGNITION THERAPEUTICS INCADAS-Cog 11 slowing in lower p-tau217 population95SEC 8-K, p.23
EISAI INCPearson correlation coefficient between amyloid PET and ADAS-Cog140.699Leqembi FDA Summary Review, p.27
Eisai Co., Ltd.ADAS-Cog14 change from baseline (PBO)5.907Leqembi EMA EPAR public assessment report, p.236
Eli Lilly and CompanyADAS-Cog13 change from baseline (donanemab vs placebo)-1.16Kisunla EMA EPAR public assessment report, p.67
SANDOZADAS-cog treatment difference-1.47Exelon FDA Review, p.37
Eli Lilly and CompanyADAS-Cog 13 treatment effect-1.33 [-20%]Kisunla FDA Review, p.11
EISAI INCChange from baseline in ADAS-Cog14-2.31Leqembi FDA Review, p.38
Eisai Co., Ltd.Pearson correlation coefficient between amyloid PET SUVR and ADAS-Cog140.699Leqembi FDA Review, p.282

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

Explore the full evidence

Every ADAS-Cog finding in the library โ€” searchable and answerable in plain language โ€” is in the Neurology research library โ†’

Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

ADAS-Cog โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Neurology