Amarantus Bioscience announced positive data for eltoprazine in a Phase 2 clinical trial of elderly patients with aggression associated with Alzheimer’s dementia.

Dementia-related behavioral symptoms, including agitation and aggression, are seen in as many as 60% of community-dwelling dementia patients and in more than 80% of nursing homes patients. Such behavioral disturbances have been associated with more rapid cognitive decline, institutionalization and increased caregiver burden. Currently, there are no approved treatments for agitation or aggression in patients with Alzheimer’s dementia.

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The Phase 2 eltoprazine study was a multicenter, double-blind, parallel-group trial in demented elderly patients with aggressive behavior. Patients were randomized to receive either eltoprazine (n=20) 1mg or 5mg, or placebo (n=9) for 29 days, with a 5 day taper-on period and a 6-8 day taper-off period. Patients were assessed for cognitive function and aggressive behavior at baseline. The primary study objectives were to collect data on the safety and tolerability of eltoprazine in the elderly. Researchers also wanted to evaluate the feasibility of the assessment methods, obtain data on the effects of eltoprazine on disruptive behavior, and to obtain preliminary data on the relationship between plasma concentrations and side-effects.

Preliminary results from the study showed that treatment with eltoprazine is associated with significant improvement in the severely aggressive eltoprazine-treated population (25.1 to 16.9) vs. placebo (22.5 to 21.5), P<0.05 as measured by the Social Dysfunction and Aggression Scale at the end of the four week treatment regimen. Further evaluation of the complete data and detailed results are underway.

Eltoprazine is a selective, small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson’s disease levodopa-induced dyskinesia (PD-LID), adult attention deficit hyperactivity disorder (ADHD), and Alzheimer’s aggression.

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