The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease (NCT04346394) | Clinical Trial Compass
WithdrawnEarly Phase 1
The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease
Stopped: COVID-19
United States0Started 2021-05-11
Plain-language summary
The goal of this clinical trial is to learn about the role of noradrenergic system in the non-motor symptoms of Parkinson's disease. The main objectives it aims to answer are:
1. To explore the association between orthostatic hypertension which is low blood pressure that occurs after going from lying to standing, and several neuropsychiatric and neurocognitive nonmotor features of Parkinson's disease (PD), such as feeling tired or disinterested and depression.
2. To explore the association between central noradrenergic dysfunction, orthostatic hypertension, and nonmotor symptoms of PD by measuring hormonal response to head up tilt-table testing before and after administration of yohimbine.
3. To explore the association between central noradrenergic dysfunction, orthostatic hypertension, and nonmotor symptoms of PD by measuring participants pupils before and after administration of yohimbine
Participants will be asked to come onsite for two study visits.
Visit one will consist of:
* Discussing and signing the Informed Consent Form
* Discussing Medical History and Current Medications
* Collecting Blood samples
* Measuring heart rate and blood pressure
* Mental health screening and neurocognitive questionnaires
* Pupil test
* Test to feel vibrations
Visit two will consist of :
* Mental Health questionnaire
* IV Placement
* Blood Draws
* Administration of Yohimbine hydrochloride
* Head up tilt table
* Measuring heart rate and blood pressure
* Answering questions about anxiety, mood, and fatigue using a scale
* Pupil tests
Visit three will be a follow-up call from the Nurse Coordinator to discuss any adverse events.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant able to provide informed consent
. Diagnosis of Parkinson's disease confirmed by a DH neurologist according to Movement Disorder Society criteria, with the exception that "Red flag" 5a will not be used (severe autonomic failure within five years of disease onset).
. All subjects must have CMP and CBC drawn within 6 months of study visit 1, with results in the normal range or with abnormal results not considered to be clinically significant in the investigator's opinion.
. Female patients must be post-menopausal (at least one year) or not planning to get pregnant and have negative pregnancy test.
Exclusion criteria
. Diagnosis or previous history of diabetes of any kind
. Known autonomic neuropathy unrelated to PD
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: All measurements for this study will be obtained during one of the two study visits that each subject will undergo. These two visits will be completed within 6 months of subject enrollment
. History of or current cardiac, liver or renal disease that, in the opinion of the investigator, may put the patient at risk because of participation in the study
. Known condition that in the investigator's opinion would be a contraindication to HUT testing or yohimbine challenge (e.g. decompensated cardiac disease, severe positional vertigo; severe anxiety, known panic disorder69)
. Current use of catecholaminergic medications (e.g. stimulants, droxidopa, midodrine) that cannot be held for at least three half-lives
. Inability to hold PD medications for at least 12 hours
. History of major depressive or bipolar disorder preceding the diagnosis of PD,69 or diagnosis or previous history of psychiatric illness that in the investigator's opinion would affect the subject's ability to successfully participate in the study.
. Any history (other than PD) that could significantly and adversely affect neurocognitive function, such as history of traumatic brain injury (head injury with loss of consciousness \> 1 hour), known dementia unrelated to Parkinson's or related diseases; developmental delay, multiple sclerosis or epilepsy with cognitive impairment, intellectual deficit, diagnosed and untreated sleep apnea; untreated syphilis; HIV with HAND; or other conditions that, based on the investigators opinion, could interfere with neurocognitive evaluation.