Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099886
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-27
First Post:
2023-08-30
Brief Title:
Repurposing Lithium for Parkinsons Disease
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Repurposing Lithium As a Disease-modifying Therapy in Parkinsons Disease a Phase I Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of lithium aspartate 30-45mgday on MRI biomarkers and blood-based therapeutic targets among 15 early-stage Parkinsons disease patients
Detailed Description:
In observational studies small daily doses of lithium 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 aspartate therapy 45mgday in PD to engage blood-based and the MRI disease progression biomarker free water to a greater extent than 15mgday or 150mgday of lithium carbonate However these blood-based and MRI biomarker findings stem from only four and two PD patients respectively who received lithium aspartate 45mgday In addition two other PD patients receiving this dosage withdrew from the study due to side effects of sedation and dizziness Subsequently one of these patients who withdrew resumed lithium aspartate at 30mgday and reported no side effects Although these findings suggest that this dosage of lithium aspartate has positive effects on PD biomarkers data from a larger number of PD patients will be required to justify conducting a larger randomized controlled trial RCT The proposed study will enroll 15 additional PD patients over five months who will receive lithium aspartate 30-45mgday for 24 weeks ensuring that the study will be completed within 12 months The dosage will be slowly titrated in each patient up to the maximum tolerated dosage in this range Blood-based biomarkers and MRIs will be assessed at baseline and 24 weeks It is anticipated that a similar magnitude of biomarker engagement will be observed among these additional 15 patients as was seen in the handful from the pilot study Such findings would provide strong preliminary evidence to support conducting a larger RCT including both clinical and biomarker outcomes Positive results from such a RCT would support lithium aspartate as a disease-modifying therapy for PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None