Rivastigmine for minor visual hallucinations in Parkinson's disease: A randomized controlled trial with 24 months follow-up.

Autor: van Mierlo TJM; Department of Neurology, Amsterdam Neuroscience, VU University Amsterdam, Amsterdam University, Medical Centers, Amsterdam, The Netherlands.; Department of Neurology, Spaarne Gasthuis, Haarlem, The Netherlands., Foncke EMJ; Department of Neurology, Amsterdam Neuroscience, VU University Amsterdam, Amsterdam University, Medical Centers, Amsterdam, The Netherlands., Post B; Department of Neurology and Centre of Expertise for Parkinson and Movement Disorders, Donders Institute for Brain Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands., Schmand BA; Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands., Bloem BR; Department of Neurology and Centre of Expertise for Parkinson and Movement Disorders, Donders Institute for Brain Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands., van Harten B; Department of Neurology, Medical Center Leeuwarden, Leeuwarden, The Netherlands., Tissingh G; Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands., Munts AG; Department of Neurology, Spaarne Gasthuis, Haarlem, The Netherlands., de Haan RJ; Clinical Research Unit, Amsterdam Neuroscience, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands., de Bie RMA; Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Brain and behavior [Brain Behav] 2021 Aug; Vol. 11 (8), pp. e2257. Date of Electronic Publication: 2021 Jul 21.
DOI: 10.1002/brb3.2257
Abstrakt: Background: Visual hallucinations are common in patients with Parkinson's disease and represent probably the major independent predictor for cognitive deterioration and nursing home placement.
Objective: To investigate if treatment of minor visual hallucinations in Parkinson's disease with rivastigmine delays the progression to psychosis.
Methods: A multicenter, randomized, double-blind, placebo-controlled trial was conducted which aimed to recruit 168 patients with Parkinson's disease reporting minor visual hallucinations 4 weeks before it. Important exclusion criteria were Parkinson's disease dementia, current delirium, and treatment with antipsychotics or drugs that have significant anti-cholinergic side effects. Subjects were randomized to rivastigmine capsules, 3-6 mg twice a day, or placebo for 24 months. The primary outcome was the time to Parkinson's disease psychosis, which was defined as the need to start with antipsychotics.
Results: The trial was stopped prematurely because of slow recruitment. Ninety-one patients were randomized: 46 patients were assigned to rivastigmine and 45 patients to placebo. No effect of rivastigmine could be demonstrated on the transition time to psychosis or dementia during the 24-month follow-up period. After 6 months of study treatment, cognition, mood, motor performance, and non-motor performance did not differ significantly between the rivastigmine-group and the placebo-group.
Conclusions: Because the study was terminated early, it was insufficiently powered to properly evaluate the primary outcome. The limited data of the study favor a wait and see approach instead of early treatment with rivastigmine in PD patients with minor VH.
(© 2021 The Authors. Brain and Behavior published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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