Parkinson DiseasePhase 2FdopaPD2NCT04459052
FDOPA PET and Nutritional Support in Parkinson's Disease
A Phase 2 study testing N acetyl cysteine and [F-18] Fluorodopa Positron Emission Tomography in people with Parkinson Disease and Idiopathic Parkinson Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The overall goal of this study will be to further our understanding of how N Acetyl Cysteine (NAC) can help to support dopaminergic function in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Idiopathic Parkinson Disease
- What is being tested?
- N acetyl cysteine and [F-18] Fluorodopa Positron Emission Tomography
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 8 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PD
- Age 30 years old and older
- Physically independent, ambulatory
- Hoehn and Yahr score of I-III inclusive.
- On stable antiparkinsonian medication for at least one month
- Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.
Who cannot join
- Known allergy to NAC
- Previous brain surgery.
- Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
- Wheelchair-bound or bed-ridden, non-ambulatory.
- Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
- History of head trauma with loss of consciousness > 48 hours.
Show all 20Show fewer
- Any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the PET-MRI imaging.
- Metal in the body that would prevent MRI scanning (as determined by the PI)
- Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
- Patients with current alcohol or drug abuse
- Pregnant or lactating women.
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
- Pending surgery during the course of the study.
- History of thrombocytopenia or clotting disorders.
- Cancer patients receiving active chemotherapy.
- Severe gastroesophageal reflux disease.
- History of uncontrolled diabetes, , gastroesophageal reflux disease, thyroid conditions
- History of uncontrolled asthma.
- History of severe kidney disease (if a patient reports this problem, a serum creatinine will be checked to assess glomerular filtration rate (GFR) and if it is less than 30, they will be excluded),
- Patients taking medications that might interact with NAC involved in this study will be evaluated on a case-by-case basis by the PI or study physician. These medications include: Medications for high blood pressure; Medications that slow blood clotting; Medications for diabetes; Nitroglycerin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase II: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
The overall goal of this study will be to further our understanding of how N Acetyl Cysteine (NAC) can help to support dopaminergic function in patients with Parkinson's disease (PD). We plan to use pre and post Positron emission tomography magnetic resonance imaging (PET-MRI) with [F-18] Fluorodopa (FDOPA) to measure dopamine function, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 ±3 months in an open label cross over design. Serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, may be conducted.
Read the detailed description
The study consists of two arms in this crossover design study. The first arm of this study will receive intravenous and oral NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC, such as its potential to counteract intracellular damage that leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative damage, protect against dopamine cell death from 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) toxicity, and to increase glutathione in blood, which might be useful in preventing oxidative damage in PD patients. The second arm will be a waitlist control receiving standard PD care. It should be noted that both arms will receive standard of care treatment for PD which will be augmented with NAC. A key component of this study is to evaluate the effects of NAC on dopamine, using PET imaging with FDOPA. Specifically, we will plan to study changes in dopamine levels before and after receiving approximately nutritional support with NAC.. This will allow us to evaluate whether NAC helps to support dopamine function. FDOPA PET imaging will be conducted at baseline and then after the nutritional support or standard of care for the waitlist arm. Then the waitlist group will receive NAC and the arm that received NAC initially will be crossed over to a standard of care group. FDOPA imaging will be conducted at the end of that period.
For evaluation of the dopamine function, [F-18] Fluorodopa (FDOPA), dose (5-10 millicurie (mCi), ± 20%) will be injected intravenously into an antecubital vein. Subjects will be premedicated with 200 mg of carbidopa orally approximately one hour prior to injection.
FDOPA has been available for over 30 years but has not been previously approved for commercial use by the FDA.We will be obtaining the FDOPA from the University of Pennsylvania cyclotron that has produced FDOPA for many Investigational New Drug applications (INDs) It will also be beneficial to assess whether there are specific changes in levels of different molecules that are related to energy consumption and oxidative stress. Proton MR spectroscopy (1H-MRS) has been previously performed in Parkinson's disease (PD) and parkinsonian syndromes to evaluate in vivo concentrations of basal ganglia and cerebral cortex metabolites such as N-acetylaspartate (NAA), choline (Cho), and creatine (Cr). We plan to include MRS as an additional biomarker to evaluate the potential effects of the nutritional supplements and/or NAC on oxidative stress and cerebral activity in PD patients.
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Being tested
- N acetyl cysteine, [F-18] Fluorodopa Positron Emission Tomography
- Keywords
- Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Central Nervous System Diseases, Movement Disorders, N acetyl cysteine, [F-18] Fluorodopa, magnetic resonance spectroscopy, PET, positron emission tomography, dopaminergic function
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteineDietary supplement
Also called NAC
Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
[F-18] Fluorodopa Positron Emission TomographyDrug
Also called FDOPA PET/MRI
FDOPA PET diagnostic imaging to to measure dopamine function, serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Oral and IV N acetyl Cysteine Cohort | Other | Administration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered). Oral NAC will be taken for approximately 6 ±3 months. Receives: Dietary Supplement: N acetyl cysteine; Drug: [F-18] Fluorodopa Positron Emission Tomography |
| Waitlist Control Cohort | Other | Standard of Care Treatment for approximately 6 ±3 months. Receives: Drug: [F-18] Fluorodopa Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDOPA PET
To evaluate if intravenous/oral NAC helps to support dopamine function in the brain of
patients with PD by using FDOPA PET imaging and subsequently helps to improve symptoms. Imaging will be conducted for standard of care and NAC arms.
Measured: Change from Baseline at approximately 6 months ± 3 months to access changes in Dopaminergic Function.
FDOPA PET
To evaluate if intravenous/oral NAC helps to support dopamine function in the brain of
patients with PD by using FDOPA PET imaging and subsequently helps to improve symptoms. Imaging will be conducted for standard of care and NAC arms.
Measured: Change from Baseline at approximately 12 months ± 3 months months to access changes in Dopaminergic Function.
Secondary outcomes (2)
Magnetic Resonance Spectroscopy (MRS)
To evaluate whether intravenous/oral NAC helps to support changes in oxidative stress and metabolism, as measured by magnetic resonance spectroscopy (MRS), in patients with PD in the standard of care and NAC arms of the study.
Measured: Change from Baseline at approximately 6 months ± 3 months to access changes in oxidative stress and metabolism..
Magnetic Resonance Spectroscopy (MRS)
To evaluate whether intravenous/oral NAC helps to support changes in oxidative stress and metabolism, as measured by magnetic resonance spectroscopy (MRS), in patients with PD in the NAC and standard of care arms of the study.
Measured: Change from Baseline at approximately 12 months ± 3 months to access changes in oxidative stress and metabolism..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start30 Apr 2020
- Primary completion11 Apr 2025
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an Open Label study. Randomization will occur via a 1:1 ratio of the NAC group and the waitlist control groups using the method of random permuted blocks with random block sizes without stratification.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel A Monti, MD, MBA, Study chair, TJU, Dept. Chair: Integrative Medicine and Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459052
- Sponsor's protocol ID
- 20D.408
- Acronym
- FdopaPD2
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2020
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.
Publications
Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
PubMed 27309537
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04459052
- Acronym / sponsor ID
- FdopaPD2 / 20D.408
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Keywords
- Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Central Nervous System Diseases, Movement Disorders, N acetyl cysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study will be to further our understanding of how N Acetyl Cysteine (NAC) can help to support dopaminergic function in patients with Parkinson's disease (PD). We plan to use pre and post Positron emission tomography magnetic resonance imaging (PET-MRI) with [F-18] Fluorodopa (FDOPA) to measure dopamine function, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 ±3 months in an open label cross over design. Serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, may be conducted.
Detailed description
The study consists of two arms in this crossover design study. The first arm of this study will receive intravenous and oral NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC, such as its potential to counteract intracellular damage that leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative damage, protect against dopamine cell death from 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) toxicity, and to increase glutathione in blood, which might be useful in preventing oxidative damage in PD patients. The second arm will be a waitlist control receiving standard PD care. It should be noted that both arms will receive standard of care treatment for PD which will be augmented with NAC. A key component of this study is to evaluate the effects of NAC on dopamine, using PET imaging with FDOPA. Specifically, we will plan to study changes in dopamine levels before and after receiving approximately nutritional support with NAC.. This will allow us to evaluate whether NAC helps to support dopamine function. FDOPA PET imaging will be conducted at baseline and then after the nutritional support or standard of care for the waitlist arm. Then the waitlist group will receive NAC and the arm that received NAC initially will be crossed over to a standard of care group. FDOPA imaging will be conducted at the end of that period.
For evaluation of the dopamine function, [F-18] Fluorodopa (FDOPA), dose (5-10 millicurie (mCi), ± 20%) will be injected intravenously into an antecubital vein. Subjects will be premedicated with 200 mg of carbidopa orally approximately one hour prior to injection.
FDOPA has been available for over 30 years but has not been previously approved for commercial use by the FDA.We will be obtaining the FDOPA from the University of Pennsylvania cyclotron that has produced FDOPA for many Investigational New Drug applications (INDs) It will also be beneficial to assess whether there are specific changes in levels of different molecules that are related to energy consumption and oxidative stress. Proton MR spectroscopy (1H-MRS) has been previously performed in Parkinson's disease (PD) and parkinsonian syndromes to evaluate in vivo concentrations of basal ganglia and cerebral cortex metabolites such as N-acetylaspartate (NAA), choline (Cho), and creatine (Cr). We plan to include MRS as an additional biomarker to evaluate the potential effects of the nutritional supplements and/or NAC on oxidative stress and cerebral activity in PD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an Open Label study. Randomization will occur via a 1:1 ratio of the NAC group and the waitlist control groups using the method of random permuted blocks with random block sizes without stratification.
| Arm | Type | Receives |
|---|---|---|
| Oral and IV N acetyl Cysteine Cohort | Other | Dietary Supplement: N acetyl cysteine, Drug: [F-18] Fluorodopa Positron Emission TomographyAdministration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered). Oral NAC will be taken for approximately 6 ±3 months. |
| Waitlist Control Cohort | Other | Drug: [F-18] Fluorodopa Positron Emission TomographyStandard of Care Treatment for approximately 6 ±3 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of PD
- Age 30 years old and older
- Physically independent, ambulatory
- Hoehn and Yahr score of I-III inclusive.
- On stable antiparkinsonian medication for at least one month
Key exclusion criteria (20 listed)
- Known allergy to NAC
- Previous brain surgery.
- Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
- Wheelchair-bound or bed-ridden, non-ambulatory.
- Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N acetyl cysteineAlso: NACIntervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered) | Dietary supplement | Oral and IV N acetyl Cysteine Cohort |
| [F-18] Fluorodopa Positron Emission TomographyAlso: FDOPA PET/MRIFDOPA PET diagnostic imaging to to measure dopamine function, serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 months. | Drug | Oral and IV N acetyl Cysteine Cohort, Waitlist Control Cohort |
Primary outcome
FDOPA PET
Time frame: Change from Baseline at approximately 6 months ± 3 months to access changes in Dopaminergic Function.
To evaluate if intravenous/oral NAC helps to support dopamine function in the brain of patients with PD by using FDOPA PET imaging and subsequently helps to improve symptoms. Imaging will be conducted for standard of care and NAC arms.
FDOPA PET
Time frame: Change from Baseline at approximately 12 months ± 3 months months to access changes in Dopaminergic Function.
To evaluate if intravenous/oral NAC helps to support dopamine function in the brain of patients with PD by using FDOPA PET imaging and subsequently helps to improve symptoms. Imaging will be conducted for standard of care and NAC arms.
2 secondary outcomes
Magnetic Resonance Spectroscopy (MRS)
Time frame: Change from Baseline at approximately 6 months ± 3 months to access changes in oxidative stress and metabolism..
Magnetic Resonance Spectroscopy (MRS)
Time frame: Change from Baseline at approximately 12 months ± 3 months to access changes in oxidative stress and metabolism..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Results publication: PubMed 27309537Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
- Individual participant dataSharing planned: Yes. After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Monti, MD, MBA study chair
TJU, Dept. Chair: Integrative Medicine and Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N acetyl cysteine and [F-18] Fluorodopa Positron Emission Tomography in people with Parkinson Disease and Idiopathic Parkinson Disease, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDOPA PET (time frame: Change from Baseline at approximately 6 months ± 3 months to access changes in Dopaminergic Function.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04459052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.