Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
Apathy usually refers to a set of behavioural, emotional and cognitive features as a reduced
interest and participation in main activities of daily life, a lack of initiative, a trend
toward an early withdrawal from started activities, an indifference and a flattening of
affect. We have validated a new specific scale (Lille Apathy Rating Scale, LARS) in order to
detect and quantify apathy in Parkinson's disease (PD). Apathy was shown to be frequent in PD
with a prevalence of 32%. It has suggested that the medial frontal and limbic cholinergic
deficits may underlie apathy in neurodegenerative disorders like Alzheimer's disease (AD).
Such a hypothesis is supported by recent evidence indicating the beneficial effects of
cholinesterase inhibitors on neuropsychiatric symptoms, mainly apathy, in AD patients. As the
efficacy of rivastigmine on cognition has also been shown in PD, we aimed to assess with a
randomized, double-blind, placebo-controlled, parallel-group, multicenter trial, the efficacy
and acceptability of a 6 months treatment with rivastigmine on apathy in 60 patients with PD
without dementia. The primary end point will be the LARS score and the secondary end points
will be the cognitive, behavioural and motor symptoms of PD. Two add-on studies will be
proposed: first the measure of choline and glutamate peaks on Magnetic Resonance Spectrometry
focused on the structures implicated in apathy in order to give insights in the
physiopathological mechanisms of the treatment. Secondly, the recording of the REM sleep
behavior disorders in relation with the cholinergic part of the pedunculopontine nucleus.
Regarding that apathy could be one of the first steps toward PD dementia, treating very early
could have substantial implications on the patients and their caregiver.