Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01986777
Status:
WITHDRAWN
Last Update Posted:
2017-09-18
First Post:
2013-10-30
Brief Title:
LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding not obtained
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LDX
Brief Summary:
This is a double-blind placebo-controlled study testing whether LDX improves cognitive function and EF in 20 postmenopausal women who report onset of cognitive difficulties after oophorectomy with or without subsequent chemoadjunctive therapy Brain imaging is included at critical time points to obtain objective data regarding effects of LDX as well as potential predictors of resilience in the face of oophorectomy
Detailed Description:
Participants will be asked to undergo three brain-imaging scans throughout the course of the study Once they are deemed eligible for participation based on two assessment visits they will be scheduled for their baseline test day On this they they will be asked to under a series of cognitive tests following by a brain-imaging scan They will then take the first dose of either the LDX or placebo wait for 3 hours and then undergo another brain-imaging scan to assess acute changes to memorycognition due to the study drug They will then come in for three 30-minute check-in visits during weeks 2 4 and 6 on the study drug They will be asked to undergo a final scan and series of cognitive tasks during weeks 8-10 on the study drug They will then be discharged from active study participation All participants regardless of randomization will be offered a consultation with the study MD and optional prescription for 4-weeks of treatment with LDX
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