Effects of lithium therapy on blood-based therapeutic targets in Parkinsons disease: treatment discontinuation/etension sub-study.
This sub-study is for Parkinson Disease (PD) patients enrolled in a previous lithium trial with Dr. Guttuso. The additional data from this sub-study may help bolster the current evidence that lithium positively affects blood biomarkers and support further research on lithium’s potential to slow PD progression.
This sub-study will determine if: 1)patients who discontinued their previous lithium therapy for at least 4 months had a return of blood-based biomarker values, including Nurr1, to their pre-study levels and, 2) if extending the duration of lithium therapy to 12 months leads to a greater magnitude of biomarker changes compared to 6 months of lithium therapy.
The purpose of the original lithium trial was to determine if 6 months of treatment with one of 3 lithium doses could positively affect certain blood-based biomarker tests that are likely to be involved with PD progression. One of the blood-based biomarkers assessed in the original trial was a protein called Nurr1. Nurr1 is a critical protein for the health and survival of dopamine brain cells.
1. Diagnosed with PD according to the UK Brain Bank Criteria.23
2. 45-80 years of age.
3. Enrolled in the previous lithium trial.
4. No history of cardiac arrhythmias besides atrial fibrillation that is rate controlled.
5. No unstable cardiac, medical or psychiatric condition in the opinion of the PI.
6. No current use of illicit drugs or current alcohol abuse in the opinion of the PI.
7. No history of hypothyroidism, not receiving thyroid replacement therapy and normal thyroid stimulating hormone (TSH) level at screening visit.
8. Estimated renal glomerular filtration rate ≥50 at last study visit
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