Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02445651
Eligibility Criteria:
Inclusion Criteria:
* Clinical Diagnosis of Parkinson's disease
* Subject is between 30 - 80 years of age
* Subject has a Hoehn and Yahr score of I - II inclusive
* Subject is on stable or on antiparkinsonian medication for at least a month
* Women of Childbearing potential will confirm a negative pregnancy test
Exclusion Criteria:
* Subject is allergic to iodine, cobalt, or any of the supplements that will be given in the study
* Subject has had previous brain surgery
* Subject has a score of 25 or less on Mini-Mental Status examination
* Subject is wheelchair-bound or bed-ridden; non ambulatory
* Subject has intracranial abnormalities that may complicate interpretation of the brain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)
* Subject has a history of head trauma with loss of consciousness greater than 48 hours
* Subject has 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 SPECT imaging.
* Subject has evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study
* Subject has a current alcohol or drug abuse
* Subject is pregnant or lactating
* Subject is enrolled in active clinical (drug or device) trial within the prior 30 days
* Subject is pending surgery during the course of the study
* History of very low blood pressure
* History of thrombocytopenia or clotting disorders
* Cancer patients receiving active chemotherapy
* History of active gallstone problems or a bile duct obstruction
* History of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid
* History of severe kidney disease (if the patient reports this problem, a serum creatinine will be checked to assess GFR; if it is less than 30, the patient will be excluded)
* History of Leber's disease, a hereditary eye disease
* History of uncontrolled hypercalcemia
* History of active sarcoidosis, histoplasmosis, or lymphoma
* Patients taking medication that might interact with the supplements involved in this study will be evaluated on a case-by-case basis by PI study physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02445651
Study Brief:
Protocol Section:
NCT02445651