Objective: The aim of the study is to investigate whether early rivastigmine treatment of visual hallucinations in patients with Parkinson’s disease delays the progression of minor visual hallucinations to Parkinson’s disease psychosis.

Background: The presence of visual hallucinations in Parkinson’s disease is an independent predictor for cognitive deterioration and nursing home placement. Cholinesterase inhibitors are recommended in Parkinson’s disease dementia but data on the effects in non-demented patients are lacking.

Method: We initiated a randomized, double blind, multicenter trial. We included patients with Parkinson’s disease that were 40 years or older and had minor visual hallucinations lasting at least four weeks. The most important exclusion criteria were Parkinson’s disease dementia, current delirium, or current treatment with antipsychotic drugs or drugs that could have significant anti-cholinergic effects. Subjects were randomized for rivastigmine capsule 6 mg BID or placebo BID with a follow up of 24 months. The primary outcome measure was the time until subjects progress to Parkinson’s disease psychosis and was defined as the start with antipsychotics. The secondary outcomes were on motor control, use of levodopa, psychotic symptoms, cognitive function, mood, adverse events, and compliance. After four years of inclusion the trial was stopped prematurely, because of a slow inclusion rate. There were many dropouts. We show the results of the trial according to the original pre-planned statistical analysis plan. In addition, we conducted an unscheduled six months follow-up, to assess the effects of rivastigmine on the short term in a larger sample size.

Results: A total of 91 patients were enrolled and randomised: 46 patients were assigned to rivastigmine and 45 patients to placebo. 21 patients using rivastigmine and 18 patients using placebo completed the follow up of 24 months. The demographic and clinical characteristics of the two groups were similar at baseline. Because only few endpoints were reached in both groups, no effect on the progression of visual hallucinations to PD psychosis could be established.  Assessment of cognition, mood, motor performance and non-motor performance did not statistically differ in the rivastigmine group compared to placebo, at baseline and after 6 months of treatment.

Conclusion: Since rivastigmine treatment is lacking short-term benefits, the use in non-demented PD patients is not recommended.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/rivastigmine-for-visual-hallucinations-in-parkinsons-disease/