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Trial of Pimavanserin in Dementia-Related Psychosis
Open accessAbstract
BACKGROUND: inverse agonist and antagonist pimavanserin on psychosis related to various causes of dementia are not clear. METHODS: We conducted a phase 3, double-blind, randomized, placebo-controlled discontinuation trial involving patients with psychosis related to Alzheimer's disease, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, or vascular dementia. Patients received open-label pimavanserin for 12 weeks. Those who had a reduction from baseline of at least 30% in the score on the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions (SAPS-H+D, with higher scores indicating greater psychosis) and a Clinical Global Impression-Improvement (CGI-I) score of 1 (very much improved) or 2 (much improved) at weeks 8 and 12 were randomly assigned in a 1:1 ratio to continue receiving pimavanserin or to receive placebo for up to 26 weeks. The primary end point, assessed in a time-to-event analysis, was a relapse of psychosis as defined by any of the following: an increase of at least 30% in the SAPS-H+D score and a CGI-I score of 6 (much worse) or 7 (very much worse), hospitalization for dementia-related psychosis, stopping of the trial regimen or withdrawal from the trial for lack of efficacy, or use of antipsychotic agents for dementia-related psychosis. RESULTS: Of the 392 patients in the open-label phase, 41 were withdrawn for administrative reasons because the trial was stopped for efficacy; of the remaining 351 patients, 217 (61.8%) had a sustained response, of whom 105 were assigned to receive pimavanserin and 112 to receive placebo. A relapse occurred in 12 of 95 patients (13%) in the pimavanserin group and in 28 of 99 (28%) in the placebo group (hazard ratio, 0.35; 95% confidence interval, 0.17 to 0.73; P = 0.005). During the double-blind phase, adverse events occurred in 43 of 105 patients (41.0%) in the pimavanserin group and in 41 of 112 (36.6%) in the placebo group. Headache, constipation, urinary tract infection, and asymptomatic QT prolongation occurred with pimavanserin. CONCLUSIONS: In a trial that was stopped early for efficacy, patients with dementia-related psychosis who had a response to pimavanserin had a lower risk of relapse with continuation of the drug than with discontinuation. Longer and larger trials are required to determine the effects of pimavanserin in dementia-related psychosis. (Funded by Acadia Pharmaceuticals; HARMONY ClinicalTrials.gov number, NCT03325556.).
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“An RCT of pimavanserin (an atypical antipsychotic with selective serotonin 5-HT2a inverse agonist effect) withdrawal in dementia-related psychosis was stopped early due to lower rates of relapse in the treatment versus placebo groups, which appeared to be driven by effects in people with Parkinson's disease .(538)”
From Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission (2024) · cites this paper as [538]
Experimental — accuracy not yet measuredIn the citing paper
“Pimavanserin (Nuplazid) Inverse agonist and antagonist of 5-HT2A in neurotransmission Completed phase 2 (2017–2019) Probable AD who has symptoms of agitation and aggression (1) Promising reduction of psychosis score in AD, also see [ 74 ] and (2) delay in psychosis relapse ( p < 0.05) and a lower risk of relapse with the continuation of the drug [ 75 ] 03118947 03325556”
From Current therapeutics for Alzheimer’s disease and clinical trials (2024) · cites this paper as [74]
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Metadata
- Authors
- Tariot, P. N., Cummings, J. L., Soto-Martin, M. E., Ballard, C., Erten-Lyons, D., Sultzer, D. L., Devanand, D. P., Weintraub, D., McEvoy, B., Youakim, J. M., Stankovic, S., & Foff, E. P.
- Affiliations
- University of Nevada, Las Vegas (US)
- From Banner Alzheimer’s Institute and University of Arizona College of Medicine, Phoenix (P.N.T.); Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas, Las Vegas (J.L.C.); Gérontopôle Alzheimer Clinical and Research Center, Centre Hospitalier Universitaire de Toulouse, Geriatric Department, Maintain Functions and Intrinsic Capacities with Aging Research Team, Center for Epidemiology and Population Health Research, INSERM, Université Paul Sabatier, Toulouse, France (M.E.S.-M.); University of Exeter School of Medicine, Exeter, United Kingdom (C.B.); the Department of Neurology, Oregon Health and Sciences University, Portland (D.E.-L.); the Department of Psychiatry and Human Behavior and the Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine (D.L.S.), and Acadia Pharmaceuticals, San Diego (B.M., J.M.Y., S.S., E.P.F.) — both in California; the Department of Ps...
- Acadia Pharmaceuticals (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-07-22
- Volume
- 385
- Issue
- 4
- Pages
- 309-319
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3184254488
- Cited by
- 145
- References
- 31
- Citations by year
- 2026: 16 · 2025: 29 · 2024: 37 · 2023: 24 · 2022: 29 · 2021: 9
- FWCI
- 17.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Figshare (submittedVersion)
- Open Research Exeter (University of Exeter) (submittedVersion)
- Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion)
- Funders
- ACADIA Pharmaceuticals
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Clinical Neurology › Parkinson's Disease Mechanisms and Treatments
- Keywords
- pimavanserin, dementia-related psychosis, Alzheimer's disease, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia, vascular dementia, relapse, delusions and hallucinations, antipsychotic withdrawal, adverse events, QT prolongation, drug discontinuation
- MeSH terms
- Aged, Aged, 80 and over, Dementia, Double-Blind Method, Female, Hallucinations, Humans, Male, Middle Aged, Parkinson Disease, Piperidines, Psychotic Disorders, Recurrence, Antipsychotic Agents, Urea, Proportional Hazards Models, Kaplan-Meier Estimate
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