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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 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.

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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.

Conditions Studied

Alzheimer Disease

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

FieldValue
Enrollment Target 48 participants
Start Date 2024-08-15
Est. Completion 2027-02
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

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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, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.