A Phase 1 interventional study of LY3954068 and Placebo in Alzheimer Disease, sponsored by Eli Lilly and Company. Recruiting at 10 sites in 3 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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 up to 4 doses of either LY3954068 or placebo administered into the spinal fluid. Participants may 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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 56 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ascending dose of LY3954068 administered intrathecally (IT)
Drug: LY3954068 · Drug: Flortaucipir F18
Single ascending dose of placebo administered IT
Drug: Placebo · Drug: Flortaucipir F18
Multiple ascending dose of LY3954068 administered IT
Drug: LY3954068 · Drug: Flortaucipir F18
Multiple ascending dose of placebo administered IT
Drug: Placebo · Drug: Flortaucipir F18
Administered IT
Administered IT
Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan
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
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
Time frame: Baseline up to Week 36 and Week 72 (for optional bridging period participants)
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 administration
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
Time frame: Baseline up to Week 76
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
To evaluate plasma concentration of LY3954068
Time frame: Day 1 up to Week 36
Part B: PK: Cmax
To evaluate plasma concentration of LY3954068
Time frame: Day -1 up to Week 76
Part A: PK: Area Under the Concentration Versus Time Curve (AUC)
To evaluate plasma concentration of LY3954068
Time frame: Day 1 up to Week 36
Part B: PK: AUC
To evaluate plasma concentration of LY3954068
Time frame: Day -1 up to Week 76
Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068
To evaluate CSF concentration of LY3954068
Time frame: Day 3 up to Week 36
Part B: PK: CSF concentration of LY3954068
To evaluate CSF concentration of LY3954068
Time frame: Day 3 up to Week 76
Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau
To evaluate the effect of LY3954068 on CSF tau
Time frame: Baseline up to Week 36
Part B: PD: Change from Baseline of CSF tau
To evaluate the effect of LY3954068 on CSF tau
Time frame: Baseline up to Week 76
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Jul 2028, 47 months after the start.
Of 160 industry-sponsored phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 47 months is above that.
Counting every sponsor, half of 233 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Feb 2027 → Jul 2028 and completion Feb 2027 → Jul 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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