Status:
TERMINATED
Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Atrium Medical Center
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's disease (PD). As an independent predictor for cognitive decline and nursing home placement they form an impo...
Detailed Description
The study is performed in four regional study centers: i.e. VUmc-AMC Amsterdam, Atrium MC Heerlen, UMC Groningen en Radboudumc Nijmegen. Each regional study center has a participating neurologist and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01856738
Start Date
November 1 2013
End Date
September 1 2018
Last Update
October 9 2018
Active Locations (4)
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1
Academic Medical Center
Amsterdam, Netherlands, 1100 DD
2
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
3
Atrium Medical Center
Heerlen, Netherlands, 6401 CX
4
University Medical Center St Radboud
Nijmegen, Netherlands, 6500 HB