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Protocol Details

Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0076

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

5-S-Cysteinyldopamine;
Cerebrospinal Fluid;
PARKINSONS DISEASE;
MONOAMINE OXIDASE INHIBITOR

Recruitment Keyword(s)

None

Condition(s)

Parkinson Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: N-Acetylcysteine
Procedure/Surgery: Lumbar Puncture
Radiation: Fluoroscopy

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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


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Citations:

Goldstein DS, Holmes C, Sullivan P, Jinsmaa Y, Kopin IJ, Sharabi Y. Elevated cerebrospinal fluid ratios of cysteinyl-dopamine/3,4-dihydroxyphenylacetic acid in parkinsonian synucleinopathies. Parkinsonism Relat Disord. 2016 Oct;31:79-86. doi: 10.1016/j.parkreldis.2016.07.009.

Goldstein DS, Kopin IJ, Sharabi Y. Catecholamine autotoxicity. Implications for pharmacology and therapeutics of Parkinson disease and related disorders. Pharmacol Ther. 2014 Dec;144(3):268-82. doi: 10.1016/j.pharmthera.2014.06.006.

Goldstein DS, Jinsmaa Y, Sullivan P, Holmes C, Kopin IJ, Sharabi Y. Comparison of Monoamine Oxidase Inhibitors in Decreasing Production of the Autotoxic Dopamine Metabolite 3,4-Dihydroxyphenylacetaldehyde in PC12 Cells. J Pharmacol Exp Ther. 2016 Feb;356(2):483-92. doi: 10.1124/jpet.115.230201.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David S. Goldstein, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Janna Gelsomino, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5653
10 Center Drive
Bethesda, Maryland 20892
(301) 435-5166
jperies@ninds.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT03104725

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