This study will assess the safety, tolerability, and biomarker efficacy of the drugs gantenerumab and solanezumab in individuals who have a genetic mutation for autosomal-dominant Alzheimer's disease.
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This Phase II/III study will target individuals who are either known to have a genetic mutation that causes autosomal-dominant Alzheimer's disease or who are unaware of their genetic status but have a parent or sibling with a known genetic mutation. Many of these high-risk participants will not yet have any symptoms of Alzheimer's. Investigators will test two experimental drugs, gantenerumab and solanezumab, to assess their safety, side effects, and effect on imaging and fluid biomarkers. Subtle, early changes in cognition will also be evaluated, though participants at this disease stage are unlikely to have more than minimal changes in cognitive measures during the study.
Because many at-risk individuals decide not to know whether they have an Alzheimer's-associated genetic mutation, some of the participants in this study will not have the disease-causing mutations. These "mutation-negative" individuals will be assigned to the placebo group. Other participants will receive one of two different therapies, gantenerumab or solanezumab. Gantenerumab is a monoclonal antibody that will be given subcutaneously (via an injection under the skin) every 4 weeks. Solanezumab is another monoclonal antibody, which will be given as an intravenous infusion every 4 weeks.
Participants and study staff will know which treatment group each participant has been assigned to. However, they will be blinded as to whether participants receive an active drug or a placebo. At the end of the study period, the sponsors will consider developing an extension study that would allow participants to continue a longer therapeutic trial with cognitive endpoints.
Although there are differences between dominantly inherited Alzheimer's disease and the more common age-associated sporadic disease, the results of this study will have implications for future studies and treatments in sporadic Alzheimer's.
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Geolocation is 38.6212468, -90.2526163
Washington University School of Medicine
Eli Lilly and Company
Randall J. Bateman, MD
Washington University in St Louis