A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT03919162
- Run by
- Vivoryon Therapeutics N.V.
- People needed
- 112
- Starts
- 2021-11-15
- Expected to finish
- 2024-08-12
- Last updated by the study team
- 2025-12-12
Who can join
Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Banner Sun Health Research Institute — Sun City, Arizona, United States
- The Neuron Clinic — Chula Vista, California, United States
- University of California — Irvine, California, United States
- UCSD Alzheimer's Disease Research Center — La Jolla, California, United States
- Cedars-Sinai Center — Los Angeles, California, United States
- PCND Neurology — Poway, California, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- USF Health Byrd Alzheimer's Center and Research Institute — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- The University of Iowa Carver College of Medicine — Iowa City, Iowa, United States
- The University of Kentucky Sanders-Brown Center on Aging — Lexington, Kentucky, United States
- Northern Light Acadia Hospital — Bangor, Maine, United States
- NYU Langone Health Tisch Hospital — New York, New York, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Ohio State University — Columbus, Ohio, United States
- OHSU Neurology Clinic — Portland, Oregon, United States
- Abington Neurological Associates — Abington, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Lowcountry Center for Veterans Research (LCVR) — Charleston, South Carolina, United States
- UT Health San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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