Lead Investigator: Paul Schulz, University of Texas Health Science Center
Title of Proposal Research: Identification of biomarkers associated with Alzheimer’s disease progression that correlate with responses to medications
Vivli Data Request: 5921
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Alzheimer’s disease (AD) manifests with strikingly different ages and sites of onset, progresses at different rates and in different anatomic directions, and has varied responses to treatment 1. Disease-modifying AD clinical trials have been disappointing; however, detailed analyses often show a subset of patients with improved outcomes 2–5. We hypothesize that AD is heterogeneous and only subsets of patients may respond to each treatment. Using computational analysis, we propose to identify biomarkers that correlate with the four critical clinical variables (age and site of onset, rate and direction of progression) and to test whether those markers correlate with responses to AD medications. The results of our analysis could provide unparalleled insights into whether a subject would respond, or not, to an investigational medication and whether a subject is likely to have rapid disease progression. It could also inform the basis of inclusion criteria for future clinical trials, ultimately increasing the likelihood of a positive outcome for both the investigational medication and the research subjects.
Requested Studies:
Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer’s Disease as Compared With Placebo
Sponsor: Eli Lilly and Company
Study ID: NCT00762411
Sponsor ID: 11271
Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 Versus Placebo
Sponsor: Eli Lilly and Company
Study ID: NCT00594568
Sponsor ID: 7666
Open-Label Extension for Alzheimer’s Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)
Sponsor: Eli Lilly and Company
Study ID: NCT01035138
Sponsor ID: 5930