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Principal Investigator  
Principal Investigator's Name: Andrew Magis
Institution: Arivale, Inc
Department: Research
Proposed Analysis: Arivale (Seattle, WA) is partnering with the Hoag Hospital (Shankle Clinic, Orange County, CA) in the Providence Health Care system and the Institute for Systems Biology (Seattle, WA) to conduct an IRB-approved clinical trial of mild cognitive impairment (MCI) progression. 200 MCI patients will be enrolled in the trial, which will run for 24 months. 100 individuals will be selected to receive standard of care at the Shankle Clinic, and 100 individuals will receive standard of care plus Arivale coaching, which will include specific lifestyle interventions shown to maintain or improve cognitive functioning in MCI based on results from the FINGER study and MIND Diet study. All 200 individuals will receive data collection through the Arivale program, which will include genomics, clinical laboratory tests, metabolomics, proteomics, and gut microbiome (16S rRNA sequencing) profiling. All assays except genomics will be collected 6 times throughout the 2-year study. The study objectives are twofold: 1) to compare cognitive changes in adults with MCI receiving routine care or data-driven health coaching in addition to routine care, and 2) to analyze longitudinal multi-omic data from participants to discover associations between measured variables and identify models of causation that further advance knowledge and research in brain degeneration and healthy living. We would like to obtain access to ADNI data to assist in data analysis for our trial. At a high level, ADNI data will be used to establish genomic, clinical, metabolomic, and/or proteomic profiles of MCI patients to be compared with similar profiles generated as part of our clinical trial. For example, ADNI data may be used for identification of perturbed analytes in MCI patients for hypothesis generation. Furthermore, we may investigate the neurocognitive correlates of perturbed analytes for potential indications of analyte relationships with brain structure and function as indicated by PET/MR image data or cognitive assessments. Alternatively, ADNI data may be used as an independent validation dataset for discoveries made as part of our trial, which might include changes in clinical laboratory tests, metabolites, or proteins as a result of disease progression. In addition, ADNI data may be useful in elucidating the neurocognitive correlates of discoveries made as part of our trial. We also have general scientific interest in Alzheimer’s disease separately from this trial and may undertake novel analyses of ADNI data for the sole purpose of peer-reviewed publication, specifically relating to multi-omic relationships between all of the aforementioned data types.
Additional Investigators  
Investigator's Name: Sergey Kornilov
Proposed Analysis: Dr. Kornilov has recently joined Arivale as a statistical geneticist. He will be participating in analysis of the Alzheimer's disease clinical trial run as a partnership with Arivale, the Hoag hospital, and the Institute for Systems Biology. The analysis plan is the same as for the Principal Investigator.