Blarcamesine Slows Progression of Motor and Nonmotor Symptoms of Parkinson Disease Dementia 

In a phase 2 study (NCT03774459), individuals with Parkinson disease dementia (PDD) treated with 50 mg/day blarcamesine had statistically significant improvement compared with those treated with placebo. Clinical efficacy was measured with the Movement Disorder Society-Unified PD Rating Scale (MDS-UPDRS). 

In individuals who received blacarmesine in addition to standard-of-care treatments, the MDS-UPDRS total score after 14 weeks improved by almost 11 points, whereas those treated with placebo had a 3.5-point worsening. The adjusted mean difference of almost 15 points (P=.038) reflects an 18.9% improvement in PDD symptoms over 14 weeks. Improvements in attention were seen as well. 

Blacarmesine is an activator of the sigma1 receptor that is thought to provide neuroprotection and restore homeostasis of neurons. In this trial, a positive effect through this mechanism was supported by the significant correlation of increased sigma 1 receptor messenger RNA with clinical improvement.

In this proof-of-concept double-blind placebo-controlled phase 2 trial 132 participants with PDD were randomly assigned (ratio of 1:1:1) to receive target doses of 30 or 50 mg blarcamesine or placebo.

Blarcamesine is also being tested in late-stage placebo-controlled phase 2b/3 trial (NCT04314934) forAlzheimer disease (AD), which recently completed enrollment.