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A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
NCT06297590 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06297590
The ClinicalTrials.gov registry entry for NCT06297590 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06297590 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06297590?
The interventions under investigation include: Placebo (DRUG), LY3954068 (DRUG), Flortaucipir F18 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06297590?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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