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Randomized Controlled Trial
. 2021 Aug;11(8):e2257.
doi: 10.1002/brb3.2257. Epub 2021 Jul 21.

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

Tom J M van Mierlo  1   2 , Elisabeth M J Foncke  1 , Bart Post  3 , Ben A Schmand  4 , Bastiaan R Bloem  3 , Barbera van Harten  5 , Gerrit Tissingh  6 , Alexander G Munts  2 , Rob J de Haan  7 , Rob M A de Bie  8 ; other individuals of the CHEVAL Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Tom J M van Mierlo et al. Brain Behav. 2021 Aug.

Abstract

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.

Keywords: Parkinson's disease; cholinesterase inhibitors; hallucinations; psychosis; randomized controlled trial.

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Conflict of interest statement

The authors have no conflict of interest to report.

Figures

FIGURE 1
FIGURE 1
Enrollment and randomization
FIGURE 2
FIGURE 2
Primary outcome: time in days before visual hallucinations progress to Parkinson's disease psychosis (Kaplan–Meier curve)
FIGURE 3
FIGURE 3
Secondary outcome: time in days before visual hallucinations progress to Parkinson's disease dementia (Kaplan–Meier curve)
FIGURE 4
FIGURE 4
Secondary outcomes: differences in scores change after six months of treatment
FIGURE 5
FIGURE 5
Compliance
See this image and copyright information in PMC

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