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The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease (NAinPD Trial)
Phase < 1
Waitlist Available
Led By Nathaniel M Robbins, MD
Research Sponsored by Nathaniel M. Robbins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how a drug called Yohimbine affects non-motor symptoms in Parkinson's disease patients, especially those with blood pressure drops when standing. By comparing patients with and without this issue, researchers hope to learn more about symptoms like depression and fatigue. Yohimbine has been shown to reduce certain movement issues in Parkinson's disease models.
Eligible Conditions
- Parkinson's Disease
- Dementia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in fatigue (measured with the self-reported Fatigue Severity Scale) in patients with Parkinson's disease with and without orthostatic hypotension (PD+OH v PD-OH)
Secondary study objectives
Change in serum catecholamine levels (supine and orthostatic) before and after yohimbine administration
Body Weight Changes
Hypotension, Orthostatic
+6 moreOther study objectives
Between group (PD+OH v PD-OH) change in diastolic blood pressure before and after yohimbine
Between group (PD+OH v PD-OH) change in time until pupillary redilation before and after yohimbine
Bronchial Provocation Tests
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: YohimbineExperimental Treatment1 Intervention
The first visit in the study has no interventional drug. Yohimbine (5mg) is administered orally during visit two, during a head up tilt test, to manipulate the noradrenergic system to determine the association between OH and NP symptoms in those with PD. Yohimbine is not administered as a treatment in this study, but as a pharmacologic tool to study the adrenergic system.
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Who is running the clinical trial?
Nathaniel M. RobbinsLead Sponsor
Nathaniel M Robbins, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center