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Principal Investigator  
Principal Investigator's Name: David Biondi
Institution: Seelos Therapeutics Inc (consultant)
Department: Clinical Development
Proposed Analysis: Our objective is to use ADNI data to develop criteria for go/no-go decision making re: do study results support proceeding to a full clinical development program (i.e., longitudinal observational data of disease progression vs data obtained in the clinical trial following study drug treatment. ADNI data will also be used to cross-validate proposed eligibility criteria for this study and feasibility to observe an effect in the proposed duration of of the study's treatment period. Brief study introduction: We are designing a proof of concept study to evaluate the safety and therapeutic effect of a novel drug in patients with MCI and mild or moderate AD. Eligibility criteria will follow NIA/AA diagnostic guidelines and must include positive PET imaging. Primary objective is to assess safety and tolerability of the investigation product. Secondary objective is to assess therapeutic effect on selected fluid and imaging biomarkers associated with AD (CSF, blood, MRI volumetrics, and PET SUVR). Exploratory objective is to assess effect on clinical measurements of cognitive performance and functioning in ADLs. Baseline values will be compared to values at 6 and 12 months.
Additional Investigators