Reduce the risk of recurrence of dementia. Phase 3 trial of innovative therapy reaches the end point

Acadia pharmaceuticals announced at the 12th clinical trial of Alzheimer's disease (ctad) conference that its serotonin receptor Reverse agonist pimavanserin reached the primary and secondary end points in the critical phase 3 trial harmony for the treatment of patients with dementia related psychosis There are about 8 million people with dementia in the United States, 30% of whom suffer from dementia related psychosis Symptoms usually include hallucinations and delusions Dementia related psychoses include Alzheimer's disease, Lewy's dementia, Parkinson's disease, vascular dementia and frontotemporal dementia Severe or persistent dementia related mental illness can lead to repeated hospitalization, premature attendance at nursing homes, rapid progression of dementia, increased incidence rate and mortality At present, there is no FDA approved drug for the treatment of dementia related psychosis on the market Pimavanserin is a selective serotonin receptor Reverse agonist (ssiA), which can selectively target 5-HT2A receptor and reduce its basic activity In humans, the activity of the 5-HT2A receptor is related to hallucinations When it is stimulated by psychedelic drugs or other agonists, the central nervous system will produce psychedelic phenomena due to excitation However, the binding of pimavanserin to 5-HT2A receptor can weaken its activity, thus reducing the excitability of the central nervous system and the risk of hallucinations or delusions In 2016, the FDA approved the drug for use in the treatment of hallucinations and delusions related to Parkinson's disease Previously, the FDA awarded pimavanserin breakthrough therapy for the treatment of dementia related psychosis A total of 392 patients with common dementia subtypes with an average age of 74.5 years participated in the critical phase 3 trial of harmony, including the placebo control group During the 12 week open label period, patients who met the pre-set remission criteria were randomly assigned to the following double-blind period and continued to receive pimavanserin or placebo The results showed that after 12 weeks of pimavanserin treatment, the symptoms of all subtypes of the patients were significantly relieved and reached a stable state 61.8% of the patients reached the pre-set remission standard at the 8th and 12th week, and the scores of saps-h + D improved by 63% and 75.2% respectively compared with the baseline, and entered the subsequent double-blind period Compared with placebo, pimavanserin reduced the risk of relapse by 2.8 times and the risk of drug withdrawal for any reason by 2.2 times "Harmony research aims to find answers to three very important questions First of all, in the 12 week treatment period, pimavanserin treatment made 5 common dementia subtypes show significant symptom relief Second, during the 26 week double-blind period, patients in the pimavanserin group had a nearly three fold lower risk of relapse compared to placebo Third, pimavanserin is well tolerated, "said Serge Stankovic, MD, President of Acadia." we look forward to discussing these results with FDA in the first half of 2020 "