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The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease

NCT04346394 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-08-23

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Yohimbine HCl

Yohimbine hydrochloride will be used to manipulate the noradrenergic system during some of the assessments. By measuring the amounts of hormones the body produces before and after yohimbine hydrochloride administration, researchers can assess how well the noradrenergic system is functioning

Sponsors & Collaborators

  • Nathaniel M. Robbins

    lead OTHER

Principal Investigators

  • Nathaniel M Robbins, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2023-08-01
Completion
2023-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346394 on ClinicalTrials.gov