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NCT06297590 · ClinicalTrials.gov registry record · Phase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
A Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 10
- Study locations
NCT06297590: Recruiting Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT06297590 is a Phase 1 study of Alzheimer Disease that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 48 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06297590, a Phase 1 study of Alzheimer Disease, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 10
- Study locations
Study Summary
The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's 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. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.
Primary Outcome
A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LY3954068
- DRUG Flortaucipir F18
Study Locations (10)
Other
- The University of Tokyo Hospital - Bunkyō City
- National Hospital for Neurology and Neurosurgery (UCLH) - London
- Royal Hallamshire Hospital - Sheffield
- University Hospital Southampton - Southampton
Florida
- K2 Medical Research, LLC - Maitland
- Charter Research, LLC - The Villages
Georgia
- CenExel iResearch, LLC (CenExel iRA) - Decatur
Massachusetts
- Massachusetts General Hospital (MGH) - Charlestown
New Jersey
- CenExel AMRI - Toms River
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT06297590 shows while recruiting
NCT06297590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06297590 lists 10 locations in 6 states (Other, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT06297590 about?
NCT06297590 is a clinical study titled "A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease". The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's 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...
What is the current status of trial NCT06297590?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-08-15. Estimated completion is 2027-02.
What conditions does trial NCT06297590 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06297590?
The interventions under investigation include: Placebo (DRUG), LY3954068 (DRUG), Flortaucipir F18 (DRUG).
Who is sponsoring clinical trial NCT06297590?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06297590 being conducted?
This trial has 10 study locations across Florida, Georgia, Massachusetts, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06297590's enrollment target sits among peer trials
48 215th of 306 higher than 90 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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