This article discussed a phase 2 trial that was conducted that studied rivastigmine’s ability to stabilize gait in individuals who have Parkinson’s disease. Before explaining the components and results of the trial, the article explained that Parkinson’s disease leads to gait variability (i.e. reductions in step length, loss of gait automaticity, etc.). Consequently, individuals with Parkinson’s disease and have developed gait are at a higher risk of falls. According to the article, gait characteristics are attributed to a loss of cholinergic function. The researchers therefore determined an acetylcholinesterase inhibitor would prevent falls by improving gait in patients with Parkinson’s disease.
The trial was performed at a hospital in the UK. Participants included those with moderate Parkinson’s disease and were stable on some type of antiparkinsonian treatment for at least 2 weeks prior to the study. They also had to be capable of walking a set distance without assistance and to have experienced at least one fall in the previous year. Patients who had already taken an acetylcholinesterase inhibitor were excluded. The trial was a 32-week long randomized placebo-controlled, double-blind, parallel-arm study. A total of 130 patients were either given rivastigmine or a placebo capsule. Participants were initially dosed at 3mg per day and eventually reached a maximum daily dose of 12 mg. Gait, balance, cognition, and mood were compared pre- and post-trial. Records of falls were also kept throughout by the patients.
The article says there was significant improvement in gait speed and controlled leaning balance in the rivastigmine group. However, fall risk, fear of falling, cognition, mood, disease severity, and quality of life measures were similar between the two groups. 23 of 65 participants stopped taking rivastigmine due to experienced adverse events. However, many of these were concluded to have not been due to rivastigmine treatment. The study found that rivastigmine participants reported more vomiting.
A discussion to conclude the article states that phase 3 trials need to be carried out in order to conclude that rivastigmine should be used to prevent falls in patients with Parkinson’s disease. The study confirmed improvement of gait in participants taking rivastigmine. However, considering the drug did not improve cognitive function in the participants, further research needs to be conducted to study if the treatment has cognitive benefit on non-cognitive impaired patients.
The Lancet Neurology. 2016;0: 1-9.
The point that was made in the closing discussion about rivastigmine’s potential for improved cognitive function in individuals without decreased cognitive function was something that had come to mind when I read that the researchers were analyzing cognition in participants. If one already has adequate acetylcholine levels, can an acetylcholinesterase inhibitor really provide any benefit?