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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44866

Enrollment

168

Registered

2013-08-06

Start date

2013-11-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic Parkinson's disease Parkinson's disease

Interventions

rivastigmine capsule 6 mg BID or placebo BID for 24 months

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the median time until PD patients with minor VH progress to major VH without insight. The clinical endpoint is defined as the start with antipsychotic treatment.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)