New drug for Alzheimer's disease
Donanemab slowed cognitive decline by 32% on the Integrated AD Rating Scale (iADRS) from baseline to 76 weeks relative to placebo.
The newly released detailed findings showed that "the use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed".
Results revealed improvement in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item cognitive subscale of the AD Assessment Scale (ADAS-Cog13), but the differences between the two treatment groups were not significant. In addition, score changes on the AD Cooperative Study-Instrumental Activities of Daily Inventory (ADCS-iADL) and the Mini-Mental State Examination (MMSE) were not "substantial."
However, the donanemab group did show an 85-centiloid greater reduction in amyloid plaque level at 76 weeks, as shown on PET, compared with the placebo group.
In summary, in patients with early symptomatic Alzheimer's disease, the treatment with donanemab met the pre-specified primary endpoint by significantly slowing disease progression on the iADRS.
The treatment also rapidly and robustly reduced amyloid plaque deposition and it slowed regional tau accumulation in the exploratory analyses.
It is the first phase 2 Alzheimer's trial to show positive results on a primary outcome measure related to memory and thinking.