Actively Recruiting
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Led by Eli Lilly and Company · Updated on 2026-04-20
48
Participants Needed
10
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18 and 40 kg/m² at screening
- Gradual and progressive memory decline for at least 6 months reported by participant or informant
- Mini Mental State Examination (MMSE) score between 18 and 30 at screening
- Clinical Dementia Rating (CDR) global score between 0.5 and 1.0, with memory box score of 0.5 or higher at screening
- Evidence of tau pathology shown by flortaucipir F18 PET scan meeting TAUVID FDA label criteria
- Males must agree to contraceptive requirements, or women must be not of childbearing potential
- Have up to 2 study partners who have contact with the participant at least 10 hours per week, with at least one able to attend study visits
You will not qualify if you...
- Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (other than Alzheimer's), psychiatric, immunologic, or hematologic disease
- Life expectancy less than 24 months
- Sensitivity to flortaucipir F18
- Contraindications to MRI, such as claustrophobia or metal implants/cardiac pacemaker
- Current exposure to amyloid targeted therapy (ATT); prior exposure allowed if over 1 year ago with investigator approval
- Previous exposure to investigational drugs given intrathecally or any anti-tau therapy
- History of significant back pain, spinal deformity, or surgery that may cause complications with lumbar puncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
K2 Medical Research, LLC
Maitland, Florida, United States, 32751
Actively Recruiting
2
Charter Research, LLC
The Villages, Florida, United States, 32162
Actively Recruiting
3
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, United States, 30030
Actively Recruiting
4
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts, United States, 02129
Not Yet Recruiting
5
CenExel AMRI
Toms River, New Jersey, United States, 08755
Actively Recruiting
6
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
7
The University of Tokyo Hospital
Bunkyō City, Japan, 113-8655
Actively Recruiting
8
National Hospital for Neurology and Neurosurgery (UCLH)
London, United Kingdom, WC1N 3BG
Actively Recruiting
9
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Not Yet Recruiting
10
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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