Clinical Trial: Effect of Exercise in Parkinsonism
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effect of Exercise on Recovery in Drug-Induced Parkinsonism and Parkinson Disease
Brief Summary: Parkinson's disease (PD) is a common neurodegenerative disorder affecting approximately 80,000 Veterans, representing a priority area for VA research. Current medicines for PD only improve symptoms, treatments that slow disease progression are needed, and earlier diagnosis of PD may be the key to their development. PD symptoms can be mimicked by medicines (most commonly antipsychotic drugs that block dopamine), and some of these patients actually have underlying "prodromal" PD that was "unmasked" years before it would have caused symptoms. This problem is increasing as these medicines are now used for common conditions including post-traumatic stress disorder and depression. The investigators will identify prodromal PD in patients with drug-induced symptoms using brain scans. These patients will be enrolled in a randomized clinical trial of aerobic exercise which slows progression in animal models of PD and has other health benefits. The investigators will measure the effect of exercise on symptoms, disease progression (using brain scans) and markers of PD risk (using blood tests). These studies will improve early PD diagnosis and potentially identify a way to slow progression of PD.
Detailed Summary:
Parkinson's disease (PD) is an incurable neurodegenerative disorder affecting approximately 1 million US adults and about 80,000 Veterans. PD causes significant morbidity due to motor and non-motor symptoms across its prolonged course with an annual economic burden of $14 billion in the US alone. Motor symptoms associated with loss of dopaminergic neurons in PD may be temporarily improved with dopamine replacing medicines, but disease-modifying therapies that delay or prevent neuronal loss are lacking and sorely needed. Exercise is promising as a disease-modifying therapy because it protects dopaminergic neurons in animal models of PD and has been associated with measures of neuroplasticity in PD patients. Unfortunately, more than half of dopaminergic neurons in the substantia nigra are lost before motor symptoms occur making it difficult to identify patients early enough to benefit from potentially disease-modifying therapies. Early "prodromal" PD can be identified using non-motor features including olfactory dysfunction and other biomarkers such as dopamine transporter (DaT) brain imaging abnormalities that are apparent years before motor symptoms. However, these strategies would be difficult and costly to implement on a population level without first identifying high-risk individuals for screening. Commonly prescribed dopamine blocking antipsychotic drugs cause debilitating PD-like motor dysfunction that is difficult to treat, and in some patients this finding may serve as a "stress test" for failing dopaminergic networks unmasking symptoms long before they would normally appear. Identifying prodromal PD among drug-induced parkinsonism patients offers a unique and unexplored opportunity for early intervention.
In the proposed studies, the investigators will employ a tiered screening strategy with inexpensive and non-invasive olfactory testing in dru
Sponsor: VA Office of Research and Development
Current Primary Outcome: change in dopamine transporter imaging [ Time Frame: 1 year ]
Original Primary Outcome: change in dopamine transporter imaging [ Time Frame: 1 year ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA Office of Research and Development
Dates:
Date Received: November 4, 2015
Date Started: February 1, 2016
Date Completion: December 2019
Last Updated: February 28, 2017
Last Verified: February 2017
