A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.

Key facts

Study ID

NCT02791191

Run by

Eli Lilly and Company

People needed

316

Starts

2016-06-16

Expected to finish

2018-07-02

Last updated by the study team

2021-04-19

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
• Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
• Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

You may not qualify if…

• Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
• Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
• Use of strong inducers of cytochrome P450 3A (CYP3A).
• Sensitivity to florbetapir or ¹⁸F-AV-1451.
• Contraindication to MRI or PET or poor venous access for blood draws.

Where it is running

• Sutter Medical Group — Sacramento, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Ray Dolby Brain Health Center/Sutter Health/CPMC — San Francisco, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• North Bay Neuroscience Institute — Sebastopol, California, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Christiana Care Health Service — Wilmington, Delaware, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• Compass Research — Melbourne, Florida, United States
• Florida International Research Center — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• The Neurology Research Group, LLC — Miami, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Sensible Healthcare — Ocoee, Florida, United States
• Meridien Research — Spring Hill, Florida, United States
• Axiom Research — Tampa, Florida, United States
• United Osteoporosis Center — Gainesville, Georgia, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Irvine Clinical Research Center — Irvine, California, United States

Full record on ClinicalTrials.gov

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