Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429059
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-04-09
Brief Title:
ROAR-DIGAP A Widely Inclusive Largely Virtual Pilot Trial Utilizing DIGAP Deep Integrated Genomics Analysis Platform To Personalize Treatments
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
ROAR-DIGAP A Widely Inclusive Largely Virtual Pilot Trial Utilizing DIGAP Deep Integrated Genomics Analysis Platform To Personalize Treatments
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
GenieUs developed an analysis platform that will be tested to separate study participants with ALS into four categories based on blood work These general categories are neuroinflammation oxidative stress impaired autophagy axonal transport and mitochondrial dysfunction Once a disease category is established participants in this study will receive one of four individualized supplements for 6 months and we will determine whether these are slowing ALS progression Astaxanthin will be given for the category of neuroinflammation Protandim for oxidative stress Melatonin for impaired autophagy and MitoQ for mitochondrial dysfunction During the first 3 months participants will have routine monitoring and in months 3 through 9 they will receive the assigned supplement
Detailed Description:
This will be a widely inclusive largely remotevirtual two-center open-label pilot trial utilizing 50 participants as their own controls Following informed consent and screening participants will provide demographics disease characteristics co-morbidities and concomitant medications They will have a baseline ALSFRS-R score obtained and blood will be drawn for DIGAP classification PBMCs which will be used to generate iPSCs from which motor neurons andor microglia can be generated baseline mechanistic biomarkers and baseline neurofilament light chain A urine pregnancy test will be obtained for pre-menopausal females who have not had one by their own doctor in the past 7 days Each month after that they will be contacted by phone by study coordinators to review adverse events new co-morbidities and concomitant medications and to generate a new ALSFRS-R score At month 3 DIGAP classification will be revealed to each participant and based on this they will receive 1 of 4 treatments They will take their assigned treatment for 6 months At months 3 5 and 9 they will be asked to return for in person blood draws for repeat mechanistic biomarkers and neurofilament light chain measurements All of the described blood tests and investigational treatments are being performed exclusively for research purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None