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

Recruitment & Eligibility

Status: Terminated

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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 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 medications or current moderate or severe disease of the skin and subcutaneous tissues - History of a major depressive episode within the past 6 months of screening - History of diagnosis of schizophrenia - History of uncontrolled bipolar disorder within past five years of screening - History of seizures within past two years of screening - Contraindication to lumbar puncture and MRI - Participation in another clinical trial for an investigational agent and having taken at least one dose of study drug, unless confirmed as having been on placebo, within 90 days prior to the baseline visit. The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2A Primary safety: proportion of participants who experience any adverse event of interest (AE-I).;2A Primary PK: derived mean values of varoglutamstat levels and corresponding calculated target occupancy (TO);2A Primary efficacy: The within-participant change from baseline to week 24 in the composite sum of standardized scores from the ADNI Battery Composite (ABC, 9-item) compared between active arm and placebo.;2A Primary efficacy:The within-participant change from baseline to week 24 in quantitative EEG (global relative theta wave power);2B Primary efficacy: The within-participant change from baseline to week 72 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score, compared between active arm and placebo.

Secondary Outcome Measures