Nuplazid Can Treat Psychosis in Alzheimer’s Patients But Benefit Only Seen in Short Term, Study Reports

Nuplazid Can Treat Psychosis in Alzheimer’s Patients But Benefit Only Seen in Short Term, Study Reports
Results from a Phase 2 clinical trial show that Nuplazid (pimavanserin) can safely treat, but possibly in the short-term only, symptoms of psychosis in Alzheimer’s patients, a study looking at data from that U.K. trial reports. An accompanying commentary, however, raised concerns about the clinical meaningfulness of these results and findings of safety. More studies are now underway. The research, “Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study,” appeared in the journal The Lancet Neurology. Approximately 25 to 50 percent of Alzheimer’s patients develop psychotic symptoms over the course of their disease. If untreated, these symptoms may become more severe, taking on a pattern of recovery and relapse. Psychosis in Alzheimer's is associated with more rapid congitive decline, earlier institutionalization, greater caregiver burden, and greater treatment-related mortality. Pimavanserin, being developed by Acadia Pharmaceuticals for dementia-related psychosis, is a selective serotonin inverse agonist that preferentially targets 5-HT2A serotonin receptors that work to transmit signals between nerve cells. In April 2016, Nuplazid became the first drug approved by the U.S. Food and Drug Administration (FDA) to treat hallucinations and delusions associated wit
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  1. Niklas Reich says:

    I agree with Schneider here – the results do not look very convincing at all. Considering its side effects, such as more frequent occurrence of falls or agitation, it is also highly doubtful that the drug reduces the need of care.

    However, the study design is improvable. Recruiting patients with a “potential” form of dementia and thus “potential” psychosis was probably not the best choice. At around the age of 85, statistics show that approximately 50 % of people develop Alzheimer’s. Assuming this, it means that the drug could only demonstrate a possible effect for half of all recruited patients. In addition, of these patients, only 25-50 % develop psychotic symptoms, as outlined in the text. The issue here? If an improvement in the majority of patients is not possible (as there is no condition to be treated to begin with), Nuplazid has/had little chance of demonstrating a statistically meaningful, better outcome for patients in the trial.

    I suppose we will have to wait and see. Nuplazid has been endorsed for Parkinson-related dementia, thus we might see a surprise in a future & better designed study.

    • Niklas Reich says:

      I need to correct myself: The patients were selected just fine. I apologise to the scientists leading the study, as I have jumped to conclusions too fast.

      Nonetheless, the other points still stand: The results of the trial are unconvincing, yet Nuplazid’s endorsement for PD-related hallucinations etc. leaves hope for future studies. Getting statistically meaningful results for this type of drug is generally very difficult.

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