FDOPA PET and Nutritional Support in Parkinson's Disease

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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). We plan to use pre and post Positron emission tomography magnetic resonance imaging (PET-MRI) with [F-18] Fluorodopa (FDOPA) 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 in an open label cross over design.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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. No metal in their 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.