Pimavanserin vs Off-Label Psychotics for Dementia-Related Psychosis: Clive Ballard, MD


The dean at the University of Exeter Medical School discussed the questions related to treating dementia-related psychosis and the options available.

“There are a lot of harms [with off-label antipsychotics], such as increased mortality, increased strokes, increase of other embolic events, like pulmonary embolism, but also falls, fractures, and accelerated cognitive decline. We also know that those become even more of a problem with long-term usage of these drugs.”

Data from a recent review of 4 studies of pimavanserin (Nuplazid; Acadia Pharmaceuticals) in patients with neurodegenerative disease (NDD) presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, by Clive Ballard, MD, professor, age-related diseases, and pro-vice-chancellor and executive dean, University of Exeter Medical School, suggest that patients did not experience negative impacts on cognitive function with up to 9 months of treatment compared to placebo.

Ballard and colleagues analyzed 4 studies and found that the Mini-Mental State Examination (MMSE) score least squares mean (LSMO change from baseline to week 12) was –0.25 (standard error [SE], 0.42) in study 019 and 0.0 (SE, 0.57) in study 032, and similar to placebo in both. LSM change from baseline to week 8 was 1.2 (SE, 0.21; n = 132) for pimavanserin and 0.5 (SE, 0.21; n = 128) for placebo in the interim analysis of study 046. The mean change from baseline to week 12 was 1.0 (SE, 0.22; n = 145) in the HARMONY study.

NeurologyLive spoke with Ballard to learn more about pimavanserin’s risk-benefit profile and the current use of off-label antipsychotics for the treatment of dementia-related psychosis (DRP). He discussed advantages to the existence of a safer treatment intended for DRP.

For more coverage of AAN 2021, click here.

Ballard C, Foff EP, Tariot P, et al. Impact of pimavanserin on cognitive measures in patients with neurodegenerative disease (NDD): results from 4 placebo-controlled clinical studies. Presented at 2021 American Academy of Neurology Annual Meeting; April 17-22. Abstract P1 012
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