A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
This is a phase 2A multi-center, randomized, double blind, placebo-controlled, parallel group
study of varoglutamstat, with a stage gate to phase 2B.
In phase 2A there will be adaptive dosing evaluation of three dose levels with exposure to
varoglutamstat or placebo for a minimum of 24 weeks, with preliminary evaluation of both
cognitive function and pharmacodynamic changes on EEG spectral analysis in approximately 180
participants.
In the event that the stage gate for phase 2B is reached, then phase 2B will assesses
efficacy and longer-term safety in a larger study group, i.e., 414.
Phase:
Phase 2
Details
Lead Sponsor:
Probiodrug AG Vivoryon Therapeutics N.V.
Collaborators:
ADCS Alzheimer's Disease Cooperative Study (ADCS) National Institute on Aging (NIA)