Varoglutamstat in Early Alzheimer's Disease

What is the Purpose of this Study?

This study focuses on individuals who have memory problems that are consistent with early Alzheimer's disease. The purpose of the study is to evaluate the safety and potential benefit of an oral investigational drug called varoglutamstat (PQ912) in Alzheimer’s disease. The study aims to identify the best dose of varoglutamstat and determine whether it delays or slows the progression of the symptoms of early Alzheimer’s disease by targeting amyloid, one of the proteins that accumulates in the brains of people with Alzheimer’s disease. Participants will be randomly assigned to receive either varoglutamstat or placebo (inactive substance).

Eligibility

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

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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat in Patients with Early Alzheimer's Disease with a Stage Gate to Phase 2B

Study Details

Disease Type/Condition

Alzheimer's disease, Memory Disorders

Principal Investigator

Kremen, Sarah

Age Group

Adult

Phase

IRB Number

STUDY00002176

ClinicalTrials.gov ID

NCT03919162

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org