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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) )
April 4, 2017
April 7, 2017
November 6, 2017
September 25, 2017
December 31, 2017   (Final data collection date for primary outcome measure)
More than or less than 10% decrease in cerebrospinal fluid level of 5-S-cysteinyldopamine [ Time Frame: 2 days ]
Same as current
Complete list of historical versions of study NCT03104725 on ClinicalTrials.gov Archive Site
  • Cerebrospinal fluid concentration of 5-S-cysteinyldopamine [ Time Frame: 2 days ]
  • Cerebrospinal fluid concentrations of neurchemicals [ Time Frame: 2 days ]
Same as current
Not Provided
Not Provided
 
Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?
Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Parkinson Disease
  • Dietary Supplement: N-Acetylcysteine
    Oral
  • Procedure: Lumbar Puncture
    procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: Janna Gelsomino, R.N. (301) 435-5166 janna.gelsomino@.nih.gov
United States
 
 
NCT03104725
170076
17-N-0076
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: David S Goldstein, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
August 8, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP