None listed
Conditions
Brief summary
We will evaluate whether Rasagiline is an effective treatment to alleviate symptoms of freezing of gait (FOG) in Parkinson’s disease. 40 patients with FOG will be randomised to either Rasagiline or placebo arms. Treatment response will be assessed by video recordings and accelerometry of specific walking tasks (Timed up and Go test), taken before and after the intervention. In addition, functional brain imaging whilst patients perform a validated virtual reality gait paradigm will be used to determine the brain activation patterns associated with improvements in FOG. The use of brain imaging will also allow us to see why patients might have differential responses to therapy. Identifying the nature of these relationships will hopefully advance our understanding of freezing.
Interventions
The study is aimed to determine whether Rasagiline reduces the frequency and severity of freezing of gait (FOG) in Parkinson’s disease (PD). PD patients suffering from FOG will be randomized to either Rasagiline, 1mg once a day, orally ingested, or an oral placebo capsule for 12 consecutive weeks. After the 12 week intervention, the patients' gait variables will be evaluated and compared to their gait variables prior the treatment. To monitor adherence to treatment, participants must return thei
The study is aimed to determine whether Rasagiline reduces the frequency and severity of freezing of gait (FOG) in Parkinson’s disease (PD). PD patients suffering from FOG will be randomized to either Rasagiline, 1mg once a day, orally ingested, or an oral placebo capsule for 12 consecutive weeks. After the 12 week intervention, the patients' gait variables will be evaluated and compared to their gait variables prior the treatment. To monitor adherence to treatment, participants must return their left over drug tablets at their last visit to enable pill count.
Sponsors
A/Prof Simon Lewis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with PD according to the United Kingdom Brain Bank clinical criteria and confirmed by a trained neurologist. Age over 18 Mini-Mental State Examination>/=24 Screening questionnaire criteria (FOG-Q) with a positive score on item 3. FOG determined by the TUG prior to randomisation. Stable medications for 1 month prior to randomisation.
Exclusion criteria
Significant psychiatric disorder or cognitive impairment (MMSE< 24) Current use of Rasagiline or medications that should be avoided with the concurrent use of Rasagiline, unless washout of more than four weeks. Galactose intolerance, LAPP lactase deficiency or glucose-galactose malabsorption. Any significant liver, kidney or autoimmune disease.
Outcome results
None listed