Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02716662
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2016-01-06
Brief Title:
Safety of Caprylic Triglycerides in ALS A Pilot Study
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Safety of Caprylic Triglycerides in ALS A Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-04
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:
The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with ALS The reason why the investigator wants to use AC-1204 in patients with ALS is to determine if by taking AC-1204 the body will make substances called ketone bodies Further if AC-1204 is well tolerated the investigators want to change the amount the participant takes to determine if the amount of ketone bodies in the blood increase in accordance with increases in the amount of AC-1204 the participant takes The investigators want to do this study because when the investigators gave AC-1204 to mice with ALS findings suggest the disease course is altered for the better and that the cause of this change is due to the presence of ketones in the blood If AC-1204 can be proven to be safe and able to cause ketones to increase in the blood the investigators will likely do subsequent studies to determine if the presence of ketone bodies will slow or stop the progression of the disease However this study is not designed to determine if AC-1204 will stop or slow the progression of ALS It is designed to only determine if patients with ALS can tolerate AC-1204 if ketone bodies are produced and if the amount of ketone bodies produced increases with increasing dose
Detailed Description:
None
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