A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring TRAILBLAZER-ALZ
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Banner Alzheimer's Institute
- Banner Sun Health Research Institute
- Neurology Center of North Orange County
- Irvine Clinical Research Center
- Institute for Memory Impairment & Neurological Disorders
- Pharmacology Research Institute
- Pacific Research Network Inc
- Sharp Mesa Vista Hospital
- Syrentis Clinical Research
- Associated Neurologists, PC - Danbury
- KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.
- JEM Research Institute
- Bradenton Research Center
- Brain Matters Research
- Infinity Clinical Research, LLC
- Jacksonville Center for Clinical Research
- Merritt Island Medical Research LLC
- Pharmax Research Clinic
- Miami Jewish Health Systems
- Suncoast Clinical Research
- Compass Research
- Palm Beach Neurological Group
- Quantum Laboratories
- Progressive Medical Research
- Intercoastal Medical Group
- Axiom Research
- Stedman Clinical Trials
- Compass Research
- Great Lakes Clinical Trials
- Alexian Brothers Medical Center
- Indiana University School of Medicine
- Josephson Wallack Munshower Neurology
- University of Kansas Hospital
- Cotton O'Neil Clinic
- McLean Hospital
- ActivMed Practices & Research, Inc
- Boston Center for Memory
- Donald S Marks
- Washington University
- Las Vegas Medical Research
- Advanced Memory Research Institute of New Jersey
- Behavioral Health Center Research
- Guilford Neurologic Associates
- Raleigh Neurology Associates
- Piedmont Medical Research
- Insight Clinical Trials
- Ohio State University Medical Center
- Neurology Diagnostics, Inc.
- Abington Neurological Associates
- Rhode Island Hospital
- Butler Hospital
- Texas Neurology, PA
- Houston Methodist
- The Memory Clinic
- Cognition Health
- National Clinical Research - Richmond
- Bruyere Research Institute
- Kawartha Regional Memory Clinic
- Toronto Memory Program
- Clinique de la Memoire de l'Outaouais
- DIEX Recherche Sherbrooke, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Donanemab Monotherapy (Donanemab-M)
Placebo
Donanemab in Combination With LY3202626 (Donanemab-C)
Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
Participants received placebo IV Q4W for up to 72 weeks.
Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks. As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.