Pimavanserin in Dementia-Related Psychosis: Clive Ballard, MD

Ballard, a professor of age related diseases at University of Exeter, discussed the results from a recent trial of pimavanserin in dementia-related psychosis, and data presented at this year’s AAIC meeting.

“Really what the study was about was…can you break that cycle? Could you have a treatment that was effective in giving sustained benefit, and did it have a good enough tolerability profile that it was safe to use over that extended time period?”

Results from a study on the use of pimavanserin (Nuplazid; Acadia) in dementia-related psychosis (DRP) were recently published in the New England Journal of Medicine and completed by safety data presented at the 2021 Alzheimer’s Association International Conference (AAIC) July 26-30, 2021.1,2 The safety data suggest that patients with neurodegenerative diseases and/or neurovascular disorders receiving pimavanserin in clinical trials commonly received concomitant antidementia medication, such as acetylcholinesterase inhibitors or memantine, and that the combination was safe and tolerable.2

Study author Clive Ballard, MD, pro-vice-chancellor and executive dean of medicine, professor of age related diseases, University of Exeter, discussed findings from the DRP study, explaining that those treated with the drug had a lower risk of psychosis relapse, as investigators work towards “breaking the cycle” of associated symptoms and offering sustained benefit for patients with DRP. In conversation with NeurologyLive, Ballard discussed the phases of the current study, as well as the effectiveness of the drug in treating psychosis in patients with Parkinson disease and other forms of dementia.1

The extended study included treatment with pimavanserin over a longer period of 6 months and non-drug lead-in to rule out viable non-pharmaceutical intervention. Those who responded well to treatment during the initial 12-week treatment, Ballard said, were included in the phase 3, double-blind, randomized, placebo-controlled discontinuation trial, in order to evaluate the effectiveness of the drug over a longer period, further considering relapse rates.

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REFERENCES
1. Tariot P, Cummings JL, Soto-Martin ME, et al. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021; 385:309-319. doi: 10.1056/NEJMoa2034634.
2. Demos G, Foff EP, McEvoy B, Skoog B. Pimavanserin and concomitant antidementia medication use in patients with neurodegenerative and/or neurovascular disorders: safety outcomes from pooled clinical data and the HARMONY study. Presented at: AAIC 2021; Denver, Colorado; July 26-30. Poster 57661.