First Participant Receives Study Treatment in Clinical Trial for Dementia with Lewy Bodies

The first participant has received a treatment in the phase 2 SHIMMER trial (NCT05225415) evaluating an antagonist of the sigma 2 progesterone receptor (CT1812; Cognition Therapeutics, New York, NY) for potential treatment of dementia with Lewy bodies (DLB). 

Anticipated enrollment is 120 adults with DLB, age 50 to 80, who will be randomly assigned receive placebo or 1 of 2 daily doses of the investigational agent for 6 months. Outcome measures include cognitive performance, physical activity, and pharmacokinetic/pharmacodynamic measures of biomarkers. Levels of α-synuclein and other proteins known to be affected by DLB will also be measured.

“DLB is a devastating disease that has no disease-modifying treatments and impacts millions of people around the globe, yet remains under-funded and under-researched,” said James E. Galvin, MD, MPH, director, Comprehensive Center for Brain Health, University of Miami Miller School of Medicine. “This phase 2 study provides me and my colleagues at other sites in the Lewy Body Dementia Consortium an opportunity to investigate a unique mechanism of action that has the potential to impact the progression of DLB.”

The accumulation of pathogenic proteins in DLB is believed to be due in part to a failure of autophagy and other key cellular functions, which evidence suggests are regulated by the sigma-2 progesterone receptor.