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Trial record 1 of 15 for:    Parkinson's disease | Recruiting Studies | United States, Maryland | NIH
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Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

This study is currently recruiting participants.
Verified August 8, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03104725
First Posted: April 7, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
  Purpose

Background:

Parkinson s disease (PD) causes slow movement, stiffness, and poor balance. Many symptoms are due to the loss of brain cells that make the brain chemical dopamine. The cells may be damaged by the breakdown of dopamine by a process called oxidation. The drug N-acetylcysteine (NAC) can act as an antioxidant. Researchers want to test if NAC can decrease the oxidation of brain dopamine in people with PD.

Objective:

To look at the effect of NAC on brain chemistry in people with PD.

Eligibility:

People ages 18 and older with PD that was diagnosed within the past 5 years. They must be taking a monoamine oxidase inhibitor.

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Participants will be hospitalized for 4 to 8 days.

On day 1, they will have blood and urine tests. They cannot eat or drink anything but water and their medications for several hours. Late in the morning they will have a meal.

About 2 hours later they will have a spinal tap. For this, a numbing medicine is injected into the back. A needle is inserted between the bones in the back to remove a small amount of fluid. The spinal tap may be use x-rays to see inside the body.

After the spinal tap, they will start taking NAC by mouth.

They will take NAC twice a day for 2 more days.

On the next day, they will not eat until a meal in the late morning. They will take a final NAC dose.

About 2 hours later they will have a second spinal tap.


Condition Intervention
Parkinson Disease Dietary Supplement: N-Acetylcysteine Procedure: Lumbar Puncture

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):

Primary Outcome Measures:
  • More than or less than 10% decrease in cerebrospinal fluid level of 5-S-cysteinyldopamine [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Cerebrospinal fluid concentration of 5-S-cysteinyldopamine [ Time Frame: 2 days ]
  • Cerebrospinal fluid concentrations of neurchemicals [ Time Frame: 2 days ]

Estimated Enrollment: 35
Actual Study Start Date: September 25, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: N-Acetylcysteine
    Oral
    Procedure: Lumbar Puncture
    procedure
Detailed Description:

Objective:

This study is to test whether N-acetylcysteine (NAC) inhibits the spontaneous oxidation of central neural dopamine as indicated by the cerebrospinal fluid (CSF) concentration of 5-S-cysteinyl-dopamine (Cys-DA) in patients with Parkinson s disease (PD).

Study population:

The study population comprises up to 35 patients with early (less than or equal to 5 years from diagnosis), mild, levodopa-untreated PD. The patients will be on an inhibitor of monoamine oxidase (MAO) that is prescribed for their disease.

Design:

The study has a one group, pretest-posttest design. Each patient undergoes a lumbar puncture (LP) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP is done after the patient has taken at least 5 doses of NAC (2 grams orally twice per day). The LP takes place about 2 hours after the last NAC dose.

Outcome measures:

The main outcome measure is the CSF concentration of Cys-DA. Other outcome measures are levels of other catecholamine-related neurochemicals or of indices of oxidative stress. Depending on the results, an exploratory study may be done involving NAC at 1 gram orally twice per day.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • PD diagnosed within the past 5 years
  • Taking a monoamine oxidase (MAO) inhibitor
  • Able to provide consent
  • At least18 years old

EXCLUSION CRITERIA:

  • Taking levodopa in any form
  • Known allergy to NAC
  • Already taking an anti-oxidant dietary supplement (e.g., Olive Leaf Extract, MitoQ)
  • A condition that would increase risk from a lumbar puncture (e.g., symptomatic spinal stenosis or myoclonus)
  • History of a post-spinal headache that required treatment with a blood patch
  • On a prescribed anti-coagulant (e.g., Coumadin, Plavix)
  • Pregnant or breast-feeding
  • History of alcohol or drug abuse
  • Any medical condition thatcould put subjects at increased risk. Potential participants are excluded who have evidence of bone marrow, liver, or kidney failure based on abnormal screening lab results.
  • On a medication that could interfere with the scientific results. An example of an exclusionary drug is the catechol-O-methyltransferase inhibitor entacapone. Tricyclic anti-depressants are another type of exclusionary drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104725


Contacts
Contact: Janna Gelsomino, R.N. (301) 435-5166 janna.gelsomino@.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: David S Goldstein, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03104725     History of Changes
Other Study ID Numbers: 170076
17-N-0076
First Submitted: April 4, 2017
First Posted: April 7, 2017
Last Update Posted: November 6, 2017
Last Verified: August 8, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
5-S-Cysteinyldopamine
Cerebrospinal Fluid
PARKINSONS DISEASE
MONOAMINE OXIDASE INHIBITOR

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Acetylcysteine
N-monoacetylcystine
Dopamine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents