A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Key facts

Study ID

NCT03367403

Run by

Eli Lilly and Company

People needed

272

Starts

2017-12-18

Expected to finish

2021-09-21

Last updated by the study team

2026-03-19

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
• MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
• Meet 18F flortaucipir PET scan eligibility criteria.
• Meet 18F florbetapir PET scan (central read) eligibility criteria.

You may not qualify if…

• Have a history of long QT syndrome.
• Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
• Contraindication to MRI.

Where it is running

• Banner Sun Health Research Institute — Sun City, Arizona, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Clinical Research Center — Irvine, California, United States
• Institute for Memory Impairment & Neurological Disorders — Irvine, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Associated Neurologists, PC - Danbury — Danbury, Connecticut, United States
• KI Health Partners, LLC d/b/a NE Inst. for Clin. Res. — Stamford, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Infinity Clinical Research, LLC — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Merritt Island Medical Research LLC — Merritt Island, Florida, United States
• Pharmax Research Clinic — Miami, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Compass Research — Orlando, Florida, United States
• Palm Beach Neurological Group — Palm Beach Gardens, Florida, United States
• Quantum Laboratories — Pompano Beach, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Intercoastal Medical Group — Sarasota, Florida, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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