Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
48 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people with early symptoms of Alzheimer's disease. Participants will receive either the study drug, LY3954068, or a placebo, and their health will be monitored over a period of up to 100 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index (BMI) between 18 and 40.
I have had memory changes for at least 6 months.
I have a mini mental state examination (MMSE) score between 18 and 30.
I have a clinical dementia rating (CDR) score between 0.5 and 1.0.
I have evidence of tau pathology as shown in a PET scan.
I have up to 2 study partners who can attend appointments.
You may not be able to join if
I have serious or unstable health issues.
I am sensitive to flortaucipir F18.
I have a contraindication to an MRI.
I am currently using an amyloid targeted therapy.
I have previously taken any investigational drug through the spine.
I have a history of significant back pain or injury.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 men…
Inclusion Criteria:
* 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 Criteria:
* 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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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