A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD (NCT03919162) | Clinical Trial Compass
TerminatedPhase 2
A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD
Stopped: It has been made the strategic decision to terminate the study. This decision to terminate the study early is not being made for safety reasons.
United States112 participantsStarted 2021-11-15
Plain-language 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.
Who can participate
Age range
50 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Age 50-89 (inclusive) at screening
* Diagnosed as having Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or Mild probable AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
* Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening
* Montreal Cognitive Assessment score (MoCA) \< 26 at screening
* Clinical Dementia Rating global score 0.5 or 1 with memory score of \> 0.5 at screening
* Positive cerebrospinal fluid (CSF) AD biomarker signature
* A brain MRI scan within 6 months of screening consistent with a diagnosis of Alzheimer's disease
* Participants must have a study partner who has frequent interaction with them (approximately \>3-4 times per week), will be present for all clinic visits, and can assist in compliance with study procedures.
Key Exclusion Criteria:
* Significant neurodegenerative diseases and causes of dementia, other than AD, including Parkinson's disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus)
* Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic Guidelines of the NIA-AA
* Hepatic impairment defined as Child-Pugh class A or more severe liver impairment
* History of moderate or severe skin reactions to medic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 2A: Number of Participants With Any Adverse Event of Special Interest (AESI)
Timeframe: From first dose to completion of 8 weeks on the full dose (Week 16)
2
Phase 2A: Median Estimated Target Occupancy (TO) of PQ912 in Cerebrospinal Fluid (CSF) at Week 24
Timeframe: Week 24, pre-dose (trough level) and 2-3h post-dose
3
Phase 2A: Median Plasma Concentrations of PQ912 at Week 24
Timeframe: Week 24, pre-dose (trough level) and 2-3h post-dose
4
Phase 2A: Change From Baseline in Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite (ABC) Score
Timeframe: 24 weeks
5
Phase 2A: Change From Baseline in Quantitative Electroencephalogram (qEEG)
Timeframe: 24 weeks
6
Phase 2B: Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score