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A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimer's Disease (J4T-MC-OLAA)

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease (J4T-MC-OLAA)

Wakayama Naohiko

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

June. 30, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

Have a body mass index (BMI) within the range 18 (17 for Japan participants) 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(TM) FDA label (TAUVI(TM) 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.

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 18F.
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 sponsor and in consultation with the sponsor.
Have previous exposure to any Investigational Medicinal Product administered 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.

Both

Alzheimer Disease

Drug: LY3954068
Administered IT
Drug: Placebo
Administered IT
Drug: Flortaucipir F18
Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan

(Study Arms)
Experimental: LY3954068 (Part A)
Single ascending dose of LY3954068 administered intrathecally (IT)
Interventions:
Drug: LY3954068
Drug: Flortaucipir F18
Placebo Comparator: Placebo (Part A)
Single ascending dose of placebo administered IT
Interventions:
Drug: Placebo
Drug: Flortaucipir F18
Experimental: LY3954068 (Part B)
Multiple ascending dose of LY3954068 administered IT
Interventions:
Drug: LY3954068
Drug: Flortaucipir F18
Placebo Comparator: Placebo (Part B)
Multiple ascending dose of placebo administered IT
Interventions:
Drug: Placebo
Drug: Flortaucipir F18

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 [ Time Frame: Baseline 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 administration [ Time Frame: Baseline 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

+81-3-5800-8743

No

United Kingdom/United States