Last updated on November 2017

Effect of LY3202626 on Alzheimer’s Disease Progression as Measured by Cerebral 18F-AV-1451 Tau-PET in Mild Alzheimer’s Disease Dementia.


Brief description of study

Effect of LY3202626 on Alzheimer’s Disease Progression as Measured by Cerebral 18F-AV-1451 Tau-PET in Mild Alzheimer’s Disease Dementia.

Detailed Study Description

Eli Lilly and Company (Lilly) is developing LY3202626, a synthetic small molecule which is a potent inhibitor of β-site amyloid precursor protein (APP)-cleaving enzyme [BACE]1, for the treatment of Alzheimer’s disease (AD). It is hypothesized that inhibition of BACE1 may slow or inhibit the progression of AD. Study I7X-MC-LLCF (LLCF), a Phase 2 study, will assess if inhibiting the production of Aβ in the brain through BACE1 inhibition with LY3202626 can slow the progression of disease as assessed by biomarkers of neurodegeneration over 52 weeks of treatment. The 18F-AV-1451 positron emission tomography (PET) scan is the primary outcome measure as a marker of disease progression for this study, to assess cerebral tau neurofibrillary tangle load and whether there are any changes with Aβ targeted BACE inhibitor treatment. The study will also assess LY3202626 pharmacokinetics (PK) and pharmacodynamics (PD; plasma Aβ), biomarkers of amyloid pathology (florbetapir PET) and neurodegeneration (volumetric magnetic resonance imaging [vMRI] and cerebral perfusion). In addition, LY3202626, Aβ, and tau in cerebrospinal fluid (CSF) will be collected in a substudy to assess the PK of LY3202626, PD (CSF Aβ), and neurodegeneration (CSF tau) within the central nervous system (CNS). Clinical outcomes including cognition, functional consequences of cognition, and safety will also be evaluated.

Clinical Study Identifier: TX9080

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