FDOPA PET and Nutritional Support in Parkinson's Disease (FdopaPD2)

July 24, 2025 updated by: Thomas Jefferson University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of PD
  2. Age 30 years old and older
  3. Physically independent, ambulatory
  4. Hoehn and Yahr score of I-III inclusive.
  5. On stable antiparkinsonian medication for at least one month
  6. 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.

Exclusion Criteria:

  1. Known allergy to NAC
  2. Previous brain surgery.
  3. Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
  4. Wheelchair-bound or bed-ridden, non-ambulatory.
  5. Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
  6. History of head trauma with loss of consciousness > 48 hours.
  7. 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.
  8. Metal in the body that would prevent MRI scanning (as determined by the PI)
  9. Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
  10. Patients with current alcohol or drug abuse
  11. Pregnant or lactating women.
  12. Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
  13. Pending surgery during the course of the study.
  14. History of thrombocytopenia or clotting disorders.
  15. Cancer patients receiving active chemotherapy.
  16. Severe gastroesophageal reflux disease.
  17. History of uncontrolled diabetes, , gastroesophageal reflux disease, thyroid conditions
  18. History of uncontrolled asthma.
  19. 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),
  20. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Oral and IV N acetyl Cysteine Cohort
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.
Dietary supplement: N acetyl cysteine
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)
Other Names:
  • NAC
Drug: [F-18] Fluorodopa Positron Emission Tomography
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.
Other Names:
  • FDOPA PET/MRI
Other: Waitlist Control Cohort
Standard of Care Treatment for approximately 6 ±3 months.
Drug: [F-18] Fluorodopa Positron Emission Tomography
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.
Other Names:
  • FDOPA PET/MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline at approximately 6 months ± 3 months to access changes in Dopaminergic Function.
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.
Change from Baseline at approximately 12 months ± 3 months months to access changes in Dopaminergic Function.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Spectroscopy (MRS)
Time Frame: Change from Baseline at approximately 6 months ± 3 months to access changes in oxidative stress and metabolism..
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.
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..
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.
Change from Baseline at approximately 12 months ± 3 months to access changes in oxidative stress and metabolism..

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Draw
Time Frame: .Change from Baseline NAC at approximately 6 months ± 3 months to assess serum concentration analysis of NAC.
Blood draw may be conducted to perform a serum concentration analysis of NAC to confirm the levels of NAC achieved. The samples are obtained before and after receiving the first and last dose of NAC.
.Change from Baseline NAC at approximately 6 months ± 3 months to assess serum concentration analysis of NAC.
Unified Parkinson's Disease Rating Scale or Movement Disorders Scale
Time Frame: Change from Baseline at approximately 6 months ± 3 months to access changes in PD symptoms.
Standardized assessment with the Unified Parkinson's Disease Rating Scale or Movement Disorders Scale to determine improvements in PD symptoms. A score of 199 on the UPDRS scale represents the worst symptoms with a score of zero representing no disability.
Change from Baseline at approximately 6 months ± 3 months to access changes in PD symptoms.
Unified Parkinson's Disease Rating Scale or Movement Disorders Scale
Time Frame: Change from Baseline at approximately 12 months to access changes in PD symptoms.
Standardized assessment with the Unified Parkinson's Disease Rating Scale or Movement Disorders Scale to determine improvements in PD symptoms. A score of 199 on the UPDRS scale represents the worst symptoms, with a score of zero representing no disability.
Change from Baseline at approximately 12 months to access changes in PD symptoms.
Profile of Mood States
Time Frame: Change from Baseline at approximately 6 months ± 3 months to access changes anxiety and mood in PD symptoms.
Profile of Mood States is a standardized self-report inventory will be administered to evaluate changes in mood, current state or traits. is a psychological rating scale used to assess transient, distinct mood states. The questionnaire contains 65 words that are rated on a scale of zero for not at all to 4 for extremely. There are 5 mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. A higher score for the total mood indicates a greater degree of mood disturbance.
Change from Baseline at approximately 6 months ± 3 months to access changes anxiety and mood in PD symptoms.
Profile of Mood States
Time Frame: Change from Baseline at approximately 12 months ± 3 months to access changes anxiety and mood in PD symptoms.
Profile of Mood States is a standardized self-report inventory will be administered to evaluate changes in mood, current state or traits. is a psychological rating scale used to assess transient, distinct mood states. The questionnaire contains 65 words that are rated on a scale of zero for not at all to 4 for extremely. There are 5 mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. A higher score for the total mood indicates a greater degree of mood disturbance.
Change from Baseline at approximately 12 months ± 3 months to access changes anxiety and mood in PD symptoms.
Beck Depression Inventory
Time Frame: Change from Baseline at approximately 6 months ± 3 months to access depression and changes in mood in PD symptoms.
Beck Depression Inventory is a 21 question self report inventory to access depression and changes in mood. The highest possible total for the whole test would be 63; the lowest possible score for the test would be zero. A higher score indicates worse symptoms of depression and mood.
Change from Baseline at approximately 6 months ± 3 months to access depression and changes in mood in PD symptoms.
Beck Depression Inventory
Time Frame: Change from Baseline at approximately 12 months ± 3 months to access depression and changes in mood in PD symptoms.
Beck Depression Inventory is a 21 question self report inventory to access depression and changes in mood. The highest possible total for the whole test would be 63; the lowest possible score for the test would be zero. A higher score indicates worse symptoms of depression and mood.
Change from Baseline at approximately 12 months ± 3 months to access depression and changes in mood in PD symptoms.
Parkinson's Disease Questionnaire-39.
Time Frame: approximately 6 months ± 3 months
Parkinson's Disease Questionnaire-39 (PDQ).is a self report inventory that will be used to access changes in Parkinson's Disease symptoms. The total score for the PDQ is the sum of the scores for the 20 items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero. Individual subscale scores for attention/concentration, retrospective memory, prospective memory, and planning/organization can also be generated by calculating the sum of specific sets of items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero.
approximately 6 months ± 3 months
Parkinson's Disease Questionnaire-39.
Time Frame: approximately 12 months ± 3 months
Parkinson's Disease Questionnaire-39 (PDQ).is a self report inventory that will be used to access changes in Parkinson's Disease symptoms. The total score for the PDQ is the sum of the scores for the 20 items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero. Individual subscale scores for attention/concentration, retrospective memory, prospective memory, and planning/organization can also be generated by calculating the sum of specific sets of items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero.
approximately 12 months ± 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Daniel A Monti, MD, MBA, TJU, Dept. Chair: Integrative Medicine and Nutritional Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20D.408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Study scan report will be offered to the subject after subject completes study

IPD Sharing Access Criteria

Access only to authorized research staff and study participants

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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