Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297590
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-01
Brief Title:
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimers Disease
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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 main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimers Disease AD The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD
The study will be comprised of two parts A and B Part B is optional and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068 Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo no active drug given into the spinal fluid If conducted each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid
The study will last up to approximately 45 weeks for Part A and if conducted 73 weeks for Part B including the screening period
If the optional bridging period is conducted participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks including the screening period
The study will be comprised of two parts A and B Part B is optional and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068 Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo no active drug given into the spinal fluid If conducted each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid
The study will last up to approximately 45 weeks for Part A and if conducted 73 weeks for Part B including the screening period
If the optional bridging period is conducted participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks including the screening period
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| J4T-MC-OLAA | OTHER | None | None |
| 2024-510604-37-00 | OTHER | None | None |
| U1111-1302-6222 | OTHER | Universal Trial Number | None |