Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?
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|ClinicalTrials.gov Identifier: NCT03104725|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 25, 2019
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.
To look at the effect of NAC on brain chemistry in people with PD.
People ages 18 and older with PD that was diagnosed within the past 5 years. They must be taking a monoamine oxidase inhibitor.
Participants will be screened with:
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 or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: N-Acetylcysteine Procedure: Lumbar Puncture Radiation: Fluoroscopy||Phase 1|
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).
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||January 4, 2021|
|Estimated Study Completion Date :||January 4, 2021|
- Drug: N-Acetylcysteine
- Procedure: Lumbar Puncture
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.
- Radiation: Fluoroscopy
If needed for lumbar puncture
- More than or less than 10% decrease in cerebrospinal fluid level of 5-S-cysteinyldopamine [ Time Frame: CSF Cys-DA at pre-treatment CSF Cys-DA at posttreatment ]The primary outcome measure is the relative change in CSF Cys-DA levels between pre and post-NAC treatment, which is calculated as: the difference of (CSF Cys-DA at pre-treatment CSF Cys-DA at post-treatment) divided by CSF Cys-DA at pre-treatment. The change will be dichotomized as decrease vs. no decrease with a threshold decrease to be determined based on the pilot study ofHVs.
- Cerebrospinal fluid concentration of 5-S-cysteinyldopamine [ Time Frame: Pre- and post-treatment ]Neurochemistry
- Cerebrospinal fluid concentrations of neurchemicals [ Time Frame: Pre- and post-treatment ]Neurochemistry
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
|Contact: Janna Gelsomino, R.N.||(301) firstname.lastname@example.org|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||David S Goldstein, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|