Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson*s disease: a multi-center placebo-controlled trial (CHEVAL)

Phase 4

Completed

Conditions: idiopathic Parkinson's disease
Parkinson's disease
10028037

Registration Number: NL-OMON44866

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 168

Inclusion Criteria

1. 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);;2. the presence of minor visual hallucinations 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;;3. age 40 years and over.

Exclusion Criteria

1. Parkinson's disease associated psychosis, defined as the need for antipsychotic drug treatment in the opinion of the treating neurologist;;2. Parkinson's disease dementia, defined by a score of 26 or lower on the Mini Mental State Examination (MSSE);;3. current delirium (caused by infection or metabolic disturbance);;4. current treatment with drugs that have important central anticholinergic effects;5. current or recent (< 6 months) treatment with Cholinesterase inhibitors, such as rivastigmine (Exelon) or galantamine (Reminyl);;6. VH in response (<= 1 month) to increase of dopamingergic treatment;;7. history of psychosis, (known) sick sinus syndrome or other arrhythmia ;8. current severe ophtalmologic disease (defined as a visual acuity score of < 0.5 based on Snellen eye test';;9. permanent stay in a nursing home;;10. no informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the median time until PD patients with minor VH<br /><br>progress to major VH without insight. The clinical endpoint is defined as the<br /><br>start with antipsychotic treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are changes in motor control, psychotic symptoms,<br /><br>cognitive impairment, mood disorders, daytime sleepiness, cholinergic<br /><br>deficiency, the number of adverse events, compliance, disability and caregiver<br /><br>burden. All relevant costs will be measured and valued.The median time until PD<br /><br>patients with minor VH progress to PD dementia is measured by means of changes<br /><br>in cognitive function. The secondary neurophysiological outcome measures are<br /><br>peak frequency, functional connectivity, topological network organisation and<br /><br>the direction of information flow. All relevant costs will be measured and<br /><br>valued.</p><br>