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 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT04273932
Eligibility Criteria:
1. Diagnosed with PD according to the UK Brain Bank Criteria.
2. 45-80yo.
3. Clinical Dementia Rating Scale score of 0 or 0.5.
4. Stable PD medications for previous 30 days and no current need for changes in the opinion of the PI.
5. No formed visual hallucinations or delusions for previous year.
6. Never taken prescription or over-the-counter lithium.
7. Stable or no diuretics for past 4 weeks and no need for changes for at least 6 months, in the PI's opinion.
8. Stable doses of antidepressants, antihypertensives and non-steroidal anti-inflammatory medications (NSAIDs) for previous 60 days and no current need to adjust such medications.
9. No history of cardiac arrhythmias besides atrial fibrillation that is rate controlled.
10. No unstable cardiac, medical or psychiatric condition in the opinion of the PI.
11. No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
12. No history of hypothyroidism, not receiving thyroid replacement therapy and normal thyroid stimulating hormone (TSH) level at screening visit.
13. Estimated renal glomerular filtration rate ≥50 at screening visit.
14. No history of receiving or planning to receive nilotinib or a glucagon-like peptide-1 agonist medication such as exenatide.
15. No use of tobacco products for the previous year.
16. No deep brain stimulation (DBS) or possible need for DBS for at least 1-year in the opinion of the PI.
17. Women with child bearing potential will need a negative pregnancy test and not be nursing an infant at screening. Women with child bearing potential will need to report using barrier method or hormonal contraception.
18. Not enrolled in another clinical trial.
19. Willing and able to sign informed consent and follow study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT04273932
Study Brief:
Protocol Section:
NCT04273932