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A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD

NCT03919162 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-12-12

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

PQ912

PQ912 150 mg tablets

OTHER

Placebo

Placebo tablets to mimic PQ912 150 mg tablets

Sponsors & Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Vivoryon Therapeutics N.V.

    lead INDUSTRY

Principal Investigators

  • Howard Feldman · Alzheimer's Disease Cooperative Study (ADCS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-07-12
Completion
2024-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919162 on ClinicalTrials.gov