Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03104725
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
2017-04-04
Brief Title:
Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinsons Disease
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with recruitment and participant accrual due to study eligibility criteria and required study procedures eg multiple lumbar punctures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Parkinsons 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 were diagnosed within the past 5 years They must be taking a monoamine oxidase inhibitor
Healthy volunteer participants ages 18 and older
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 participants will have blood and urine tests For several hours they cannot eat or drink anything but water and their medications Late in the morning they will have a meal
About 2 hours later they will have a spinal tap lumbar puncture 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 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
Healthy Volunteer HV participants will receive a spinal tap on day one followed by a second spinal tap 48 hours after the first spinal tap HV participants will not receive NAC
Parkinsons 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 were diagnosed within the past 5 years They must be taking a monoamine oxidase inhibitor
Healthy volunteer participants ages 18 and older
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 participants will have blood and urine tests For several hours they cannot eat or drink anything but water and their medications Late in the morning they will have a meal
About 2 hours later they will have a spinal tap lumbar puncture 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 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
Healthy Volunteer HV participants will receive a spinal tap on day one followed by a second spinal tap 48 hours after the first spinal tap HV participants will not receive NAC
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 Parkinsons disease PD
Study population
The study population comprises up to 35 participants with early less than or equal to 5 years from diagnosis mild levodopa-untreated PD and up to 6 healthy volunteer participants The PD participants will be on an inhibitor of monoamine oxidase MAO that is prescribed for their disease
Design
The study has a two groups employing a pretest-posttest design Each participant undergoes a lumbar puncture LP as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid CSF for assays of Cys-DA 34-dihydroxyphenylacetic acid DOPAC and related biochemicals For PD participants the second LP is done after the participant 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 For HV participants the second LP takes place approximately 48 hours after the first LP
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
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 Parkinsons disease PD
Study population
The study population comprises up to 35 participants with early less than or equal to 5 years from diagnosis mild levodopa-untreated PD and up to 6 healthy volunteer participants The PD participants will be on an inhibitor of monoamine oxidase MAO that is prescribed for their disease
Design
The study has a two groups employing a pretest-posttest design Each participant undergoes a lumbar puncture LP as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid CSF for assays of Cys-DA 34-dihydroxyphenylacetic acid DOPAC and related biochemicals For PD participants the second LP is done after the participant 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 For HV participants the second LP takes place approximately 48 hours after the first LP
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-N-0076 | None | None | None |