Early blarcamesine use slows AD progression over 3 years
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Topline results from a phase 2b/3 clinical trial of blarcamesine for individuals with early-stage Alzheimer’s disease showed that earlier initiation of the oral therapeutic led to significant disease slowing over 3 years.
In a press release, manufacturer Anavex Life Sciences said the ATTENTION-AD clinical trial followed the 48-week ANAVEX2-73-AD-004 double-blind study with an open-label extension examining safety and tolerability of blarcamesine as well as long-term effects of the drug on cognition and function in participants with early AD. Treatment duration was 96 weeks for participants in North America and Europe and up to 144 weeks for participants in Australia.
Disease progression was measured by scores on the Alzheimer’s Disease Assessment Scale-Cognitive 13 (ADAS-Cog13), a neurocognitive battery.
According to the release, analysis for ADAS-Cog13 showed a significant difference between early start and late start treatment groups at week 144 (LS mean difference -2.7, P = 0.0348), which favored those who started early.
The positive treatment difference, shown by a mean ADAS-Cog13 difference of more than 2 points, increased up to week 192 (LS mean difference -3.83, P = 0.0165), suggesting that those given early blarcamesine intervention demonstrated more stable cognitive function compared with those who were initiated approximately 1 year later.
Blarcamesine additionally exhibited a favorable safety profile with the majority of adverse events mild to moderate in severity and mostly a result of the initial titration phase.
No new safety findings were observed over the 3-year treatment regimen and no deaths related to the study drug were recorded.
“These results demonstrate that diagnosing and treating people earlier in the progression of Alzheimer's disease may lead to greater clinical benefit,” Juan Carlos Lopez-Talavera, MD, PhD, head of research and development of Anavex, said in the release. “Additionally, the comprehensive data from the blarcamesine Alzheimer’s disease program represents a solid foundation for the subsequent strategy of our phase 3 and 4 development plan.”