Back to search results

Early Alzheimer's Disease Study of LY3954068

This study is testing a new drug called LY3954068 for people with early symptoms of Alzheimer's disease. The main goal is to see if LY3954068 is safe. Researchers will also look at how the drug moves through the body and if it affects signs of Alzheimer's. You might be able to join if you are 50 to 85 years old, have experienced memory changes for at least six months, and have a Mini Mental State Exam (MMSE) score between 18 and 30. Some participants will receive LY3954068, and others will receive a placebo (an inactive substance) given into the spinal fluid. The study will measure any side effects to determine the drug's safety.

Study design
This is a first-in-human interventional study with a planned enrollment of 48 participants. It has two parts: Part A involves a single dose, and Part B involves two doses of either LY3954068 or placebo.
What's involved
Participants in Part A will receive one dose, and participants in Part B will receive two doses of the study drug or placebo, administered into the spinal fluid. You will also have a PET scan after receiving Flortaucipir F18 intravenously.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part A will be followed for safety up to 24 weeks, and potentially up to 72 weeks if they join an optional bridging period. Participants in Part B will be followed for safety up to 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06297590

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

Recruiting
PHASE1Ages 50–85InterventionalBasic science
Eli Lilly and Company
~48 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY3954068PlaceboFlortaucipir F18

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Measured over Baseline up to Week 24 and Week 72 (for optional bridging period participants)
+1 more outcome measured

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's Disease

Where it's being run

10 sites across 7 states
United Kingdom3
Florida2
Georgia1
Massachusetts1
New Jersey1
North Carolina1
Japan1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Have a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²), inclusive, at screening.
Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant.
Have a mini mental state examination (MMSE) score of 18 to 30 at screening.
Have a clinical dementia rating (CDR) global score of 0.5 to 1.0, with a memory box score ≥ 0.5 at screening.
Meet flortaucipir F18 positron emission tomography (PET) criteria, as defined in the TAUVID™ FDA label (TAUVID™ prescribing information, 2024), demonstrating evidence of tau pathology.
Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
Participants must have up to 2 study partners who are with contact with the participant at least 10 hours per week and one of whom can attend study appointments.

Exclusion

Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (other than Alzheimer's Disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of less than (\<)24 months.
Have a sensitivity to flortaucipir F18.
Have contraindication to magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
Have a current exposure to an amyloid targeted therapy (ATT). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.
Have previous exposure to any Investigational Medicinal Product administered intrathecal (IT) or previous exposure to any anti-tau therapy.
Have a history of clinically significant back pain, back pathology and/or back injury (for example, degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture.

What this trial measures

  • Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administrationBaseline up to Week 24 and Week 72 (for optional bridging period participants)

    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

  • Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administrationBaseline up to Week 52

    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