A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Stage Gate to Phase 2B (VIVA-MIND)

Grants and Contracts Details

Description

Study Description: The VIVAMIND study will be conducted as a public-private partnership with shared leadership responsibility across Vivoryon Therapeutics and the Alzheimer''s Disease Cooperative Study (ADCS), under a single protocol. This is a phase 2A multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial in participants with early AD, with a stage gate to phase 2B. Phase 2A will determine the highest dose of varoglutamstat that is safe and well tolerated with sufficient plasma exposure and a calculated TO in CSF. During this phase, continuous safety evaluation using a pre-defined safety stopping boundary will help determine which dose will be carried forward into phase 2B. In addition, at the end of phase 2A, an interim analysis of both cognitive function using an ADNI Battery Composite (ABC) and pharmacodynamic changes on EEG spectral analysis will be conducted to inform a stage gate decision on whether to proceed with phase 2B. In the event that the stage gate for phase 2B is reached, the study will continue and phase 2B will assess efficacy and longer-term safety of varoglutamstat in a larger group of participants through 72 weeks of treatment. Throughout the remainder of the trial, all participants will be randomized to this optimal selected dose from phase 2A or placebo.
StatusActive
Effective start/end date1/1/216/30/24

Funding

  • University of California San Diego Health: $123,397.00

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