Purpose

A clinical trial to determine if Varoglutamstat (PQ912) is effective in slowing effects of Alzheimer's Disease

Category

IRB Number
20220043HU
NCT Number
NCT03919162
Open to Enrollment
Yes
Sponsor
Vivoryon Therapeutics N.V. -



Study Contact

Principal Investigator
Sudha Seshadri

Floyd Jones
+1 (210) 450-3158
jonesfa@uthscsa.edu

Sudha Seshadri
(210) 450-8437
Seshadri@uthscsa.edu



Eligibility

Eligible Ages
50-89 inclusive
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Diagnosed with Mild Cognitive Impairment due to AD or Mild probable AD. 

    Have had an MRI w/in the Past Six Months

    Have a study partner who has frequent interaction with the participant (3-4 times per week) and can accompany the participant to all visits.  

Exclusion Criteria

    Have been diagnosed with a disease known to cause dementia including (but not limited to) Parkinson's Disease, Huntington disease, Lewy Body Disease, or AIDS. 

    Have a mental illness judged to be not well controlled in the opinion of the PI. 

    Medical Contraindications to undergoing an MRI or Lumbar Puncture. 

    Have a medical condtion determined to be not well controlled on medication in the opinion of the PI.   


Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Condition
  • Alzheimer Disease

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    600 mg

    		First 4 weeks 150 mg BID, week 5-8 300 mg BID, week 9-24 600 mg BID
  • Drug: PQ912

    PQ912 150 mg tablets

    Other names:

    • Varoglutamstat

    • Experimental

    150 mg

    		24 weeks on 150 mg BID
  • Drug: PQ912

    PQ912 150 mg tablets

    Other names:

    • Varoglutamstat

    • Experimental

    300 mg

    		First 4 weeks 150 mg BID, week 5-24 300 mg BID
  • Drug: PQ912

    PQ912 150 mg tablets

    Other names:

    • Varoglutamstat

    • Placebo Comparator

    Placebo

  • Other: Placebo

    Placebo tablets to mimic PQ912 150 mg tablets

    •