dr. E.M.J. Foncke
Vumc
Netherlands
CHEVAL-in: neurophysiological determinants of conversion to psychosis and response to cholinesterase inhibitors in Parkinson's disease
Parkinson Vereniging
39,609
01/12/2015
1
Visual hallucinations (VH) are the most common non-motor symptoms in
Parkinsons disease (PD). As an independent predictor for cognitive decline and
nursing home placement they form an important disability milestone in the
course of PD. According to current clinical guidelines minor VH do not require
treatment per se. But as minor VH precede the stage of major VH without insight
and PD associated psychosis (PDP) they offer an opportunity for early
intervention. Neuroleptic drugs delay the transition into PDP but are
unsuitable for early treatment of VH due to their side effects. We hypothesize
that cholinesterase inhibitors (ChEI) are a well-tolerated alternative for the
early treatment of minor VH to delay the progression to PDP and that brain
network analysis is suitable to predict treatment response.
Objective of the study:
investigate whether early treatment with ChEI delays the progression of minor
VH to major VH without insight or PDP. In addition, we will measure motor
control, psychotic symptoms, cognitive impairment, mood disorders, adverse
events and compliance, disability, caregiver burden and care use. We assess the
cost-effectiveness of early chronic treatment of VH with ChEI. Finally, we
analyse changes of functional brain networks before and during treatment.
Study design:
a randomized, double blind, placebo-controlled, multi-center trial with an
economic evaluation.
Study population:
168 patients with PD and VH after fulfilling the in-and exclusion criteria.
https://www.toetsingonline.nl/to/ccmo_search.nsf/fABRpop?readform&unids=B1190B25CAC6E1B1C1257FB10015140C