Status:
ACTIVE_NOT_RECRUITING
FDOPA PET and Nutritional Support in Parkinson's Disease
Lead Sponsor:
Thomas Jefferson University
Conditions:
Parkinson Disease
Idiopathic Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 p...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04459052
Start Date
April 30 2020
End Date
January 8 2027
Last Update
July 29 2025
Active Locations (1)
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1
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States, 19107