Phase
Condition
N/ATreatment
PQ912
Placebo
Clinical Study ID
Ages 50-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theNational 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 atscreening
Positive CSF AD biomarker signature
A brain MRI scan within 6 months of screening consistent with a diagnosis ofAlzheimer'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 canassist in compliance with study procedures.
Exclusion
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 SupranuclearPalsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressurehydrocephalus)
Meeting Diagnostic Criteria for Possible AD according to workgroups of theDiagnostic 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 orsevere 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 havingtaken 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 investigationaltrial is defined as the date of the last dose of an investigational agent.
Study Design
Study Description
Connect with a study center
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
The Neuron Clinic
Chula Vista, California 91910
United StatesSite Not Available
University of California
Irvine, California 92868
United StatesSite Not Available
UCSD Alzheimer's Disease Research Center
La Jolla, California 92037
United StatesSite Not Available
Cedars-Sinai Center
Los Angeles, California 90048
United StatesSite Not Available
PCND Neurology
Poway, California 92064
United StatesSite Not Available
Georgetown University Medical Center
Washington, District of Columbia 20057
United StatesSite Not Available
USF Health Byrd Alzheimer's Center and Research Institute
Tampa, Florida 33613
United StatesSite Not Available
Emory University
Atlanta, Georgia 30329
United StatesSite Not Available
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesSite Not Available
The University of Iowa Carver College of Medicine
Iowa City, Iowa 52242
United StatesSite Not Available
The University of Kentucky Sanders-Brown Center on Aging
Lexington, Kentucky 40504
United StatesSite Not Available
Northern Light Acadia Hospital
Bangor, Maine 04401
United StatesSite Not Available
NYU Langone Health Tisch Hospital
New York, New York 10016
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
OHSU Neurology Clinic
Portland, Oregon 97239
United StatesSite Not Available
Abington Neurological Associates
Abington, Pennsylvania 19001
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Lowcountry Center for Veterans Research (LCVR)
Charleston, South Carolina 29403
United StatesSite Not Available
UT Health San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
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