Rivastigmine as an early treatment for visual hallucinations in Parkinson’s disease (CHEVAL)

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 18.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001722-25-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

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 clinical trial of medicinal product
• Study Design: Not specified