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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01856738
• Date of registration: 14/05/2013
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease CHEVAL
• Scientific title: Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.
• Date of first enrolment: November 2013
• Target sample size: 91
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01856738
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Elisabeth Foncke, Dr.
• Affiliation: VU University Medical Center

Key inclusion & exclusion criteria

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.

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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo (for rivastigmine)

Drug: Rivastigmine

Primary Outcome(s)

time to start with antipsychotic treatment for visual hallucinations [Time Frame: 24 months]

Secondary Outcome(s)

EEG frequency band analysis [Time Frame: 12 months]

caregiver burden [Time Frame: 24 months]

cholinergic deficiency [Time Frame: 24 months]

adverse events [Time Frame: 24 months]

cognitive function [Time Frame: 24 months]

EEG power analysis [Time Frame: 12 months]

psychotic symptoms [Time Frame: 24 months]

daytime sleepiness [Time Frame: 24 months]

EEG flow direction [Time Frame: 12 months]

EEG functional connectivity [Time Frame: 12 months]

EEG topological network organisation [Time Frame: 12 months]

motor control [Time Frame: 24 months]

care use [Time Frame: 24 months]

mood disturbance [Time Frame: 24 months]

compliance [Time Frame: 24 monhts]

disability [Time Frame: 24 months]

Secondary ID(s)

2013-001722-25

NL44622.029.13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

University Medical Center Nijmegen

University Medical Center Groningen

International Parkinson Fonds Germany GmbH

Leiden University Medical Center

Atrium Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development