Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880849
Status:
RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-05-10
Brief Title:
Choline Effects - Pre-symptomatic AD
Sponsor:
Paul E Schulz
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers
Status:
RECRUITING
Status Verified Date:
2024-08
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 test the safety tolerability and effects of choline in people with increased risk of Alzheimers Disease AD also known as pre-symptomatic AD Choline is a dietary supplement but is being investigated to see if it has any effects on the progression to AD
Detailed Description:
The purpose of this study is to determine the safety and tolerability as well as the biochemical effects of choline bitartrate over a 6-month treatment period in a moderately sized population harboring at least one copy of the APOE4 gene APOE is a protein involved in lipid transport Studies show that the APOE4 variant is strongly associated with an increased risk of Alzheimers Disease It is unclear how APOE4 results in an increased risk for AD but a recent study identified a novel molecular pathway which showed that APOE4-induced dysfunction of lipid metabolism in neurons by cellular accumulation of unsaturated lipids The investigators hypothesize that choline supplementation normalizes the APOE4-mediated dysregulation by normalizing the Kennedy pathway in neuronal cells thus stabilizing the lipid metabolism and concomitantly restoring normal cell function by increasing phosphatidylcholine activity via the Kennedy pathway To evaluate this the investigators will test if choline supplementation will decrease the ratio of unsaturated lipids to saturated lipids the fatty acid desaturation index in cerebrospinal fluid by 15 and increase phosphatidylcholine by 100
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?:
None
Is an FDA AA801 Violation?:
None