EUCTR2013-001722-25-NLActive, not recruitingPhase 1
Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson’s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVA
VU University Medical Center0 sites168 target enrollmentStarted: August 12, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 168
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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.
- •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.
Investigators
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