Evidence map›Paper›PMID 34291590›Full record

Trial reportBrain and behavior2021

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

Tom J M van Mierlo, Elisabeth M J Foncke, Bart Post, Ben A Schmand, Bastiaan R Bloem, Barbera van Harten, Gerrit Tissingh, Alexander G Munts, Rob J de Haan, Rob M A de Bie and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Brain and behavior, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Review
  5. Observational
  6. Article
  7. Review
  8. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Tom J M van MierloDepartment of Neurology, Amsterdam Neuroscience, VU University Amsterdam, Amsterdam University, Medical Centers, Amsterdam, The Netherlands.ORCID 0000-0002-5933-0288
Elisabeth M J FonckeDepartment of Neurology, Amsterdam Neuroscience, VU University Amsterdam, Amsterdam University, Medical Centers, Amsterdam, The Netherlands.
Bart PostDepartment of Neurology and Centre of Expertise for Parkinson and Movement Disorders, Donders Institute for Brain Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands.
Ben A SchmandDepartment of Psychology, University of Amsterdam, Amsterdam, The Netherlands.
Bastiaan R BloemDepartment of Neurology and Centre of Expertise for Parkinson and Movement Disorders, Donders Institute for Brain Cognition and Behaviour, Radboudumc, Nijmegen, The Netherlands.
Barbera van HartenDepartment of Neurology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
Gerrit TissinghDepartment of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands.
Alexander G MuntsDepartment of Neurology, Spaarne Gasthuis, Haarlem, The Netherlands.
Rob J de HaanClinical Research Unit, Amsterdam Neuroscience, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Rob M A de BieDepartment of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
other individuals of the CHEVAL Study Group
Amsterdam Neuroscience · NLRadboud University Nijmegen · NLSpaarne Ziekenhuis · NLMedisch Centrum Leeuwarden · NLUniversity of Amsterdam · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVisual hallucinations are common in patients with Parkinson's disease and represent probably the major independent predictor for cognitive deterioration and nursing home placement.

objectiveTo investigate if treatment of minor visual hallucinations in Parkinson's disease with rivastigmine delays the progression to psychosis.

methodsA 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.

resultsThe 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.

conclusionsBecause 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.

Indexed as

Parkinson DiseaseCholinesterase InhibitorsFollow-Up StudiesHallucinationsHumansPhenylcarbamatesRivastigmineCholinesterase InhibitorsPhenylcarbamatesRivastigminecholinesterase inhibitorshallucinationsParkinson's diseasepsychosisrandomized controlled trial

Identifiers

PMID34291590
PMCPMC8413762
OpenAlexW3184714752

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.