Dr Emily Henderson
A randomised control trial of rivastigmine versus placebo for improving gait stability in patients with Parkinson's with a past history of a fall
Parkinson's disease & PD-related disorders
Pharmacology | Clinical studies
Does rivastigmine improve gait stability, balance and freezing of gait in patients with Parkinson’s disease (PD) with a past history of a fall?
Aim: To evaluate the role of cholinesterase inhibitor therapy on gait in patients with PD.
Objectives: To undertake clinical trial to assess the effect of rivastigmine on gait and balance, attention and executive function, falls and freezing of gait.
Design: A single centre, double blind placebo controlled randomised control trial.
Methodology: Patients with idiopathic Parkinson’s disease without dementia and with a history of having fallen will be recruited and enrolled. Participants will be randomised in a 1:1 allocation. The intervention group will receive rivastigmine and the control group, placebo. The primary outcome measure is gait variability and assessments will be performed at 0,4,24 and 28 weeks. Falls follow up will continue for 1 year. or control and receive placebo. The main analyses will be performed using the intention to treat principle. We will use multivariable linear, logistic and proportional hazard regression models as appropriate.
Implications: Gait variability, a marker of gait stability, is a surrogate marker of falls risk. Predictive models of falls risk will be validated along with novel methods of assessing freezing. The findings will facilitate scientific understanding of the aetiological mechanisms underlying axial symptoms. It will support or refute the role of cholinesterase inhibitors for falls in PD.