A drug typically prescribed for dementia may help prevent debilitating falls in people with Parkinson’s disease, according to a study, “Rivastigmine for gait stability in patients with Parkinson’s disease (ReSPonD): a randomised, double-blind, placebo-controlled, phase 2 trial,” published in the journal The Lancet Neurology.
Falls are a frequent and serious complication of Parkinson’s disease (PD), partly related to an underlying cholinergic deficit that contributes to gait and cognitive dysfunction in PD patients. The study’s researchers found that patients treated with the oral drug rivastigmine — a drug commonly prescribed for dementia patients — were 45 percent less likely to fall and were considerably steadier when walking compared with patients given a placebo.
“With the degeneration of dopamine producing nerve cells, people with Parkinson’s often have issues with unsteadiness when walking. As part of the condition, they also have lower levels of acetylcholine, a chemical which helps us to concentrate — making it extremely difficult to pay attention to walking,” Dr. Emily Henderson, the study’s principal investigator at the University of Bristol and a Parkinson’s UK Research Fellow, said in a news release. “We already know that rivastigmine works to treat dementia by preventing the breakdown of acetylcholine, however our study shows for the first time that it can also improve regularity of walking, speed, and balance. This is a real breakthrough in reducing the risk of falls for people with Parkinson’s.”
Dr. Henderson and colleagues conducted a randomized, double-blind, placebo-controlled Phase 2 clinical trial involving 130 PD patients. All the patients had fallen at least once in the year before enrollment, were able to walk 18 meters without aid, had no previous exposure to an acetylcholinesterase inhibitor, and no dementia diagnosis. Half of the patients were given rivastigmine capsules (n=65) and the other half (n=65) a placebo for the study period’s eight months. Dosage was increased over 12 weeks from 3 mg per day to the target dose of 12 mg per day.
The primary endpoint was difference in step time variability between the two groups at 32 weeks, adjusted for baseline age, cognition, step time variability, and number of falls in the previous year.
“People affected by Parkinson’s, their careers, and health and social care professionals have said that preventing falls and improving balance is the biggest unmet need for people living with the condition, other than finding a cure. Things that may be simple to us, such as walking upstairs or getting up in the middle of the night to get a glass of water, or go to the toilet, are much harder and more dangerous when you could easily fall,” said Dr. Arthur Roach, director of Research at Parkinson’s UK. “This trial shows that there may be drugs already available, being used for other purposes, that can be tested to help treat Parkinson’s. This takes us a step closer to improving the quality of life and finding better treatments for people with Parkinson’s.”
Researchers say that a Phase 3 study is needed to confirm these findings and establish the cost-effectiveness of rivastigmine treatment.
PD affects 127,000 people in the United Kingdom and about seven million worldwide. Estimates indicate that about 70 percent of Parkinson’s patients fall at least once a year, with over a third experiencing frequent falls, leading to fractures, broken bones and hospital admissions.
Caroline Maxwell, a study participant diagnosed with Parkinson’s 13 years ago, added, “A few years ago, I had a bad fall while carrying my sewing machine across the room, leaving me in hospital for a week and really denting my confidence. I’m at the stage where I would walk much better with a replacement joint, but because I fall so frequently my surgeon is reluctant to operate. … By potentially finding a treatment that helps to prevent falls, I’d be able to get a replacement hip and have the confidence to go shopping on my own, without having to constantly rely on the goodness of strangers to pick me up.”