NCT04346394: NAinPD

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

Withdrawn EARLY_PHASE1 Last updated 23 August 2023

What this trial tests

EARLY_PHASE1 trial testing Yohimbine HCl in Parkinson Disease. Withdrawn.

Timeline

11 May 2021

Primary endpoint
1 August 2023

1 August 2023

Quick facts

Lead sponsor	Nathaniel M. Robbins
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Start date	11 May 2021
Primary completion	1 August 2023
Estimated completion	1 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Yohimbine HCl — full drug profile →

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Nathaniel M. Robbins — full company profile →

Who can join

Eligibility, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of adrenergic receptor signalling in neuroimmune communication.
   Chhatar S, Lal G. · · 2021 · cited 76× · PMID 35492402 · DOI 10.1016/j.crimmu.2021.11.001
2. Nanotherapeutic Interventions for Parkinson's Disease: Modulating Pathogenic Mechanisms and Overcoming Therapeutic Obstacles.
   Yin X, Wang C, Lin W, Huang S, et al · · 2026 · PMID 41907367 · DOI 10.2147/ijn.s570452