Trial reportThe journal of prevention of Alzheimer's disease2019
Pimavanserin in Alzheimer's Disease Psychosis: Efficacy in Patients with More Pronounced Psychotic Symptoms.
Trial report in The journal of prevention of Alzheimer's disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled it
- Exploring Adjunctive Novel Therapeutic Approach of KarXT (Xanomeline-Trospium Chloride) for Managing Psychotic Symptoms in Patients With Schizophrenia and Alzheimer's Disease.Brain and behavior · 2026Review
- Clinical Practice Guidelines for Dementia: Recommendations for the Pharmacological Treatment of Behavioral and Psychological Symptoms.Dementia and neurocognitive disorders · 2025Article
- Behavioral and Psychological Symptoms (BPSD) in Alzheimer's Disease (AD): Development and Treatment.Current topics in behavioral neurosciences · 2025Review
- Neurodegenerative Diseases: New Hopes and Perspectives.Current molecular medicine · 2024Review
- Pimavanserin Use in Lewy Body Dementia: A Case Report Demonstrating the Medication's Efficacy.Cureus · 2023Article
- Pimavanserin Treatment for Psychosis in Patients with Dementia with Lewy Bodies: A Case Series.The American journal of case reports · 2023Article
- Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HTNeurology. Clinical practice · 2023Article
- The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2023Article
- Fountain of youth-Targeting autophagy in aging.Frontiers in aging neuroscience · 2023Review
- Management in severe dementia: recommendations of the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology.Dementia & neuropsychologia · 2022Article
- Psychosis in Alzheimer disease - mechanisms, genetics and therapeutic opportunities.Nature reviews. Neurology · 2022Review
- Psychosis as a Treatment Target in Dementia: A Roadmap for Designing Interventions.Journal of Alzheimer's disease : JAD · 2022Review
- Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China.Frontiers in neurology · 2022Review
- Searching for new drugs for the treatment of dementia-related psychosis.Postepy psychiatrii neurologii · 2021Review
- Progress in mechanistically novel treatments for schizophrenia.RSC medicinal chemistry · 2021Review
- Relevance of 5-HTCNS drugs · 2021Review
- Pivotal mental states.Journal of psychopharmacology (Oxford, England) · 2021Review
- Pimavanserin, a 5HTJournal of neurochemistry · 2021Article
- Pimavanserin for the treatment of psychosis in Alzheimer's disease: A literature review.World journal of psychiatry · 2020Article
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPimavanserin is a 5-HT2A receptor inverse agonist/antagonist and is approved in the United States for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
objectiveEvaluate the efficacy of pimavanserin on symptoms of psychosis in patients with Alzheimer's disease (AD).
designRandomized, double-blind, placebo-controlled trial.
settingNursing home residents.
participantsPatients with AD psychosis.
interventionsPimavanserin 34 mg or placebo daily for 12 weeks. MEASUREMENTS: The primary endpoint was mean change from baseline at Week 6 on the Neuropsychiatric Inventory-Nursing Home Version psychosis score (NPI-NH-PS). In the prespecified subgroup analysis, the mean change in NPI-NH-PS and the responder rates among those with baseline NPI-NH-PS ≥12 were evaluated.
resultsOf 181 patients randomized (n=90 pimavanserin; n=91 placebo), 57 had baseline NPI-NH-PS ≥12 (n=27 pimavanserin; n=30 placebo). In this severe subgroup, large treatment effects were observed (delta=-4.43, Cohen's d=-0.73, p=0.011), and ≥30% improvement was 88.9% vs. 43.3% (p<0.001) and ≥50% improvement was 77.8% vs. 43.3% (p=0.008) for pimavanserin and placebo, respectively. The rate of adverse events (AEs) in the severe subgroup was similar between treatment groups, and urinary tract infection, fall, and agitation were most frequent. Serious AEs was similar with pimavanserin (17.9%) and placebo (16.7%) with fewer discontinuations due to AEs with pimavanserin (7.1%) compared to placebo (10.0%). Minimal change from baseline occurred for the mean MMSE score over 12 weeks.
conclusionsPimavanserin demonstrated significant efficacy in AD psychosis in patients with higher baseline severity of psychotic symptoms (NPI-NH-PS ≥12). Treatment with pimavanserin showed an acceptable tolerability profile.
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Registered trials
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