Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With Statins
Overview
- Phase
- Not Applicable
- Intervention
- Intravenous Infusion
- Conditions
- Parkinson Disease
- Sponsor
- VA Office of Research and Development
- Enrollment
- 93
- Locations
- 3
- Primary Endpoint
- Peak Unified Dyskinesia Rating Score (UDysRS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System.
Detailed Description
Long term treatment with levodopa, the gold standard treatment of Parkinson's disease (PD), can lead to the development of abnormal involuntary movements called levodopa induced dyskinesia (LID). The severity of LID can range from mild to severely debilitating. A majority of PD patients will develop LID in their treatment life-time. In a recent study of the MPTP monkey model of PD, statin use was found to reduce LID (45%) without a worsening of Parkinsonism symptoms1. Another study showed rats treated with lovastatin prior to and with initiation of levodopa after substantia nigra lesioning showed dramatically less LID evolution compared to animals without lovastatin exposure2. In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System. This study is a retrospective three cohort design and will compare statin exposure BEFORE beginning LD, versus statin exposure AFTER LD is begun, versus NO statin exposure in PD subjects controlling for disease characteristics (severity), gender, and total LD exposure The primary endpoint is the severity of LID between the groups after years of opportunity to develop LID. Levodopa-Induced dyskinesia is a major cause of reduced quality of life for Veterans with PD and, in some cases, leads to costly surgical interventions. This project examines the impact of statin use on the presence of LID, and could lead to a future intervention trial. The reduction, delayed onset, or elimination of LID could improve the quality of life of many Veterans nationwide.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parkinson's Disease
- •Age diagnosed with Parkinson's Disease greater than or equal to 50 years
- •Treatment with levodopa greater than or equal to 5 years
Exclusion Criteria
- •Deep Brain stimulation
- •Unable to stand for 1 minute intervals, or sensory deficits in the feet
- •Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \< 18
- •Subjects with unstable medical or psychiatric conditions (including hallucinations).
- •History of unstable medical conditions (i.e. active cardiac disease, recent unwellness, surgery etc.)
- •Current use of drugs that may affect parkinsonism or dyskinesia:
- •dopamine receptor blocking medications
- •amiodarone
- •tetrabenazine
- •metoclopramide
Arms & Interventions
Statin Before Levodopa
Historical use of a statin BEFORE beginning levodopa
Intervention: Intravenous Infusion
Statin After Levodopa
Historical use of a statin AFTER beginning levodopa
Intervention: Intravenous Infusion
No Statin
No historical use of a statin
Intervention: Intravenous Infusion
Outcomes
Primary Outcomes
Peak Unified Dyskinesia Rating Score (UDysRS)
Time Frame: 11:00 am
The Unified Dyskinesia Rating Scale (UDysRS) combines patient, caregiver, and treating physician perspectives on both historical (Parts 1 \& 2) and objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The historical portion and the objective ratings are added together to form total score ranging from 0 to 104 with higher scores indicating more severe dyskinesia.
Secondary Outcomes
- Peak Unified Dyskinesia Rating Scale - Objective Measures(11:00 am)
- Presence/Absence of Levodopa-induced Dyskinesia (LID).(Every half hour from 0900 to 1500)
- Clinical Dyskinesia Rating Scale (Peak)(11:00 am)