Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease

Phase 4

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo (for rivastigmine); Drug: Rivastigmine

• Registration Number: NCT01856738
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's disease (PD). As an independent predictor for cognitive decline and nursing home placement they form an important disability milestone in the course of PD. According to current clinical guidelines minor VH do not require treatment per se. But as minor VH precede the s...

Detailed Description

The study is performed in four regional study centers: i.e. VUmc-AMC Amsterdam, Atrium MC Heerlen, UMC Groningen en Radboudumc Nijmegen. Each regional study center has a participating neurologist and will station a research nurse - of which some part-time. VUmc-AMC is also national coordinating center and their research nurse is also national trial manager....

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Study Start: 2013-11
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry (in accordance with clinical diagnostic criteria of the UK PD Society Brain Bank);
• the presence of minor VH for at least 4 weeks, defined by a score of 1 or 2 on the hallucinations item of the Unified Parkinson's Disease rating Scale (UPDRS)1-MDS;
• age 40 years and over.

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Exclusion Criteria

• Parkinson's Disease Psychosis, defined as the need for antipsychotic drug treatment in the opinion of the treating neurologist;
• Parkinson's Disease Dementia, defined by a score < 24 on the Mini Mental State Examination (MMSE);
• current delirium (caused by infection or metabolic disturbance);
• current treatment with amantadine (Symmetrel) or anti-cholinergics, such as trihexyfenidyl (Artane) or biperideen (Akineton);
• current or recent (<6 months) treatment with Cholinesterase inhibitor, such as rivastigmine (Exelon) or galantamine (Reminyl);
• recent (<1 month) change in dopaminergic therapy;
• history of psychosis or severe ophtalmologic disease (e.g. Charles Bonnet syndrome);
• permanent stay in a nursing home;
• no informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for rivastigmine)	placebo capsule for oral use 6,0 mg BID during 24 months of follow-up
Rivastigmine	Rivastigmine	rivastigmine capsule for oral use 6,0 mg BID during 24 months of follow-up

Primary Outcome Measures

Name	Time	Method
time to start with antipsychotic treatment for visual hallucinations	24 months	the time until Parkinson's disease patients with minor visual hallucinations progress to major visual hallucinations without insight (according to UPDRS 1 - MDS). The clinical endpoint is defined as the start with antipsychotic treatment.

Secondary Outcome Measures

Name	Time	Method
motor control	24 months	change in motor control measured by UPDRS 3 - MDS
psychotic symptoms	24 months	change in occurence or severity of psychotic symptoms according to Scale of Assessment of Positive Symptoms (SAPS) and UPDRS 1 MDS.
cognitive function	24 months	change in cognitive function as measured by Mini Mental State Examination, Montreal Cognitive Assessment, Parkinson's Disease - Cognitive Rating Scale
cholinergic deficiency	24 months	Cholinergic deficiency, as a possible predictor for response to treatment, measured with the Cholinersterase Inhibitor Prognosticator
EEG topological network organisation	12 months	topological network organisation (minimum spanning tree)
EEG power analysis	12 months	peak frequency / relative power analysis
compliance	24 monhts	Compliance to treatment measured by the number of remaining capsules after every 6 months of follow-up
caregiver burden	24 months	Caregiver burden according to the Zarit Caregiver Burden Inventory
adverse events	24 months	Number and type of adverse events
disability	24 months	Disability based on the AMC Linear Disability Score
EEG flow direction	12 months	direction of information flow (directed phase lag index)
EEG frequency band analysis	12 months	EEG analysis per frequency band
mood disturbance	24 months	Mood disturbance according to the Hospital Anxiety and Depression Scale
daytime sleepiness	24 months	Daytime sleepiness on the Epworth Sleepiness Scale
care use	24 months	Care use measured with the EuroQol-5D
EEG functional connectivity	12 months	functional connectivity (phase lag index)

Trial Locations

Locations (4)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Atrium Medical Center; 🇳🇱 Heerlen, Netherlands

University Medical Center St Radboud; 🇳🇱 Nijmegen, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands