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
SexALL
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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
✕. 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)
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
. 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.