Our successful randomised controlled trial of pimavanserin, a novel treatment for psychosis in Parkinson’s Disease has now been published in The Lancet. The trial showed that pimavanserin is both safe and effective in this patient group and we are currently actively participating in submissions for regulatory approval, including a new drug application to the US Food and Drug Administration (FDA)
We also are now hosting a phase III trial of pimavanserin in people with Alzheimer’s Disease, recruited through the NIHR Maudsley Biomedical Research Centre (BRC) Care Home Research Network. This work represents effective translation of novel findings across disease states, and provides the opportunity for a novel treatment with a far better safety profile than the existing antipsychotic medications. The implications for people with dementia and psychosis are substantial. It is hoped that pimavanserin will soon be available for use in practice as a viable alternative to atypical antipsychotics.
The pimavanserin trial also used novel methodology to reduce placebo response rates, a major problem in randomised controlled trials of neuropsychiatric symptoms in people with dementia. We developed a brief psychosocial therapy adapted for Parkinson's disease to help elicit a placebo response ahead of the drug administration. The psychosocial therapy consisted of daily social interactions between participant and caregiver based on a plan tailored to their interests and capabilities. This approach has been approved and commended by the FDA and literature reviews by leading European and North American groups and has been used in the recent high impact CITAD study examining the treatment of agitation in people with Alzheimer’s Disease using citalopram in the US. We have been involved in advisory board and partnership discussions with other pharmaceutical companies who are interested in using our brief psychosocial therapy approach in future trials.