A Single & Multiple-Dose Study to Evaluate LY3954068 in Pts with AD
Research type
Research Study
Full title
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
IRAS ID
1009783
Contact name
Teodora Andrian
Contact email
Sponsor organisation
Eli Lilly & Co
Eudract number
2024-510604-37
Clinicaltrials.gov Identifier
Research summary
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.
LY3954068 is a new type of drug called an oligonucleotide that is designed to reduce the levels of tau protein Clumping of tau protein in the brain known as neurofibrillary tangles (NFTs) are one of the pathologic hallmarks of AD, linking tau aggregation to neurodegeneration. It is thought that reducing tau levels may slow the clinical progression of AD.
LY3954068 will be given to the participant as a 10 minute infusion into the fluid that surrounds the brain via the spinal column which is intended to enable the distribution to the brain.
The study is comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period, which is a period where participants remain in the study with no study drug. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug). If conducted, each participant in Part B would receive several doses of either LY3954068 or placebo.
The study will last approximately 69 weeks for Part A and will involve approximately 14 on site visits; other visits can be done via a phone call. If conducted the study will last approximately, 73 weeks for Part B and will involve approximately 17 on site visits, other visits can be done via a phone call. If conducted, the optional bridging period would last up to 1 year after their completion of Part A.
Participants in Part A will have approximately 7 Magnetic Resonance Imaging (MRI) scans, 3 Flortaucipir Positron Emission Tomography-Computed Tomography (PET-CT) brain scans and 5 lumbar punctures; While participants in Part B will have approximately 5 MRI scans and 3 Flortaucipir PET-CT brain scans and 7 lumbar punctures.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0362
Date of REC Opinion
8 Jul 2024
REC opinion
Further Information Favourable Opinion