Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592014
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Lithium for Parkinsons an Extension Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Repurposing Lithium As a Disease-modifying Therapy in Parkinsons Disease an Open-label Extension Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 025-050mmolL on MRI and blood-based biomarkers in Parkinsons disease patients who have completed one of our current 24-week lithium clinical trials
Detailed Description:
In observational studies small daily doses of lithium from smoking cigarettes have been associated with a 77 reduced risk of developing Parkinsons disease PD In addition lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several PD animal models Recently our group has shown 24-weeks of low-dose lithium therapy in PD to be associated with improvements in both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease However these findings stemmed from only three of four patients receiving MRIs Our group is now conducting two larger studies enrolling a total of 35 PD patients who are being treated with either 45mgday or 20mgday of lithium or placebo therapy for 24 weeks Because our earlier study showed maximum improvements in PD biomarkers in patients with serum lithium levels of 025-050mmolL and there are large interpatient variations in serum lithium levels achieved from the same lithium dosage this present study will adjust lithium dosing in each patient to achieve this target serum lithium level for an additional 24 weeks MRI and blood-based biomarker changes from Baseline will be compared in patients with serum lithium levels 025mmolL and 025mmolL from one of the 24-week studies and within individual patients Results from this study may identify a target serum lithium level range associated with maximum improvements in PD biomarkers that can be used in the design of future larger lithium PD lithium trials which may eventually support lithium as a disease-modifying therapy for PD that could improve patients long-term prognoses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None