Phase
Condition
Dementia
Treatment
ATH-1017
Placebo
Clinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Age 55 to 85 years
Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
Clinical diagnosis of dementia, due probably to AD, by Revised National Institute onAging-Alzheimer's Association criteria (McKhann, 2011)
Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
Reliable and capable support person/caregiver
Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI]treatment), defined as:
Treatment-naïve, OR
Subjects who received an AChEI in the past and discontinued at least 4 weeksprior to Screening
Exclusion
Key Exclusion Criteria:
History of significant neurologic disease, other than AD, that may affect cognition,or concurrent with the onset of dementia
Subject has atypical variant presentation of AD, if known from medical history,particularly non-amnestic AD
History of brain MRI scan indicative of any other significant abnormality
Diagnosis of severe major depressive disorder even without psychotic features.
Significant suicide risk
History within 2 years of Screening, or current diagnosis of psychosis
Myocardial infarction or unstable angina within the last 6 months
Clinically significant cardiac arrhythmia (including atrial fibrillation),cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
Subject has either hypertension or symptomatic hypotension
Clinically significant ECG abnormality at Screening
Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min
Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2times the upper limit of normal, or Child-Pugh class B and C
Malignant tumor within 3 years before Screening
Memantine in any form, combination or dosage within 4 weeks prior to Screening
Acetylcholinesterase inhibitors in any dosage form
The subject has received active amyloid or tau immunization (i.e., vaccination forAlzheimer's disease) at any time, or passive immunization (i.e., monoclonalantibodies for Alzheimer's disease) within 6 months of Screening
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Xenoscience
Phoenix, Arizona 85004
United StatesSite Not Available
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
ATP Clinical Research, Inc
Costa Mesa, California 92626
United StatesSite Not Available
Wr - Pri, Llc
Encino, California 91316
United StatesSite Not Available
Neurology Center of North Orange County
Fullerton, California 92835
United StatesSite Not Available
Sun Valley Research Center, Inc.
Imperial, California 92251
United StatesSite Not Available
Irvine Clinical Research
Irvine, California 92614
United StatesSite Not Available
Sunwise Clinical Research
Lafayette, California 94549
United StatesSite Not Available
Healthy Brain Research Inc
Long Beach, California 90804
United StatesSite Not Available
PRI Research
Los Alamitos, California 90720
United StatesSite Not Available
PRI Research
Newport Beach, California 92660
United StatesSite Not Available
Pacific Research Network
San Diego, California 92103
United StatesSite Not Available
Southern California Research, LLC
Simi Valley, California 93065
United StatesSite Not Available
Viking Clinical
Temecula, California 92591
United StatesSite Not Available
Denver Neurological Research, LLC
Denver, Colorado 80210
United StatesSite Not Available
Mile High Research Center
Denver, Colorado 80218
United StatesSite Not Available
CenExel RMCR
Englewood, Colorado 80113
United StatesSite Not Available
JEM Research Institute
Atlantis, Florida 33462
United StatesSite Not Available
Boynton Beach Medical Research Institute
Boynton Beach, Florida 33437
United StatesSite Not Available
K2 Medical Research Winter Garden
Clermont, Florida 34711
United StatesSite Not Available
Accel Clinical Research
DeLand, Florida 32720
United StatesSite Not Available
Brain Matters Research
Delray Beach, Florida 33445
United StatesSite Not Available
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida 33912
United StatesSite Not Available
Reliable Clinical Research LLC
Hialeah, Florida 33012
United StatesSite Not Available
K2 Medical Research-The Villages
Lady Lake, Florida 32159
United StatesSite Not Available
Wr-Msra, Llc
Lake City, Florida 32055
United StatesSite Not Available
JEM Research Institute
Lake Worth, Florida 33462
United StatesSite Not Available
ClinCloud
Maitland, Florida 32751
United StatesSite Not Available
Merritt Island Medical Research
Merritt Island, Florida 32952
United StatesSite Not Available
Global Medical Institutes, LLC dba South Miami Medical Institute
Miami, Florida 33125
United StatesSite Not Available
Innova Pharma
Miami, Florida 33175
United StatesSite Not Available
Optimus U Corp
Miami, Florida 33125
United StatesSite Not Available
Quantix Research
Miami, Florida 33155
United StatesSite Not Available
K2 Medical Research Maitland
Orlando, Florida 32751
United StatesSite Not Available
Accel Clinical Research
Port Orange, Florida 32127
United StatesSite Not Available
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Accel Clinical Research
Saint Petersburg, Florida 33709
United StatesSite Not Available
Mart Medical Group Research
South Miami, Florida 33143
United StatesSite Not Available
Premiere Research Institute
West Palm Beach, Florida 33407
United StatesSite Not Available
Accel Clinical Research
Decatur, Georgia 30030
United StatesSite Not Available
CenExel iResearch, LLC
Decatur, Georgia 30030
United StatesSite Not Available
CenExel
Savannah, Georgia 31405
United StatesSite Not Available
Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
Honolulu, Hawaii 96817
United StatesSite Not Available
Rush Alzheimer's Disease Center, Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
SIU Medicine Neuroscience Institute (NSI)
Springfield, Illinois 62794
United StatesSite Not Available
Indiana University School of Medicine, Department of Neurology
Indianapolis, Indiana 46202
United StatesSite Not Available
Ochsner Clinical Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Northern Light Acadia Hospital
Bangor, Maine 04401
United StatesSite Not Available
PharmaSite Research
Baltimore, Maryland 21208
United StatesSite Not Available
Massachusetts General Hospital
Charlestown, Massachusetts 02129
United StatesSite Not Available
Activmed Practices & Research, Inc.
Lowell, Massachusetts 01852
United StatesSite Not Available
Boston Center for Memory
Newton, Massachusetts 02459
United StatesSite Not Available
Adams Clinical
Watertown, Massachusetts 02472
United StatesSite Not Available
Clinical Research Professionals
Chesterfield, Missouri 63005
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United StatesSite Not Available
M3 Wake Research
Las Vegas, Nevada 89106
United StatesSite Not Available
Hackensack Meridian Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey 08540
United StatesSite Not Available
Advanced Memory Research Institute of NJ
Toms River, New Jersey 08755
United StatesSite Not Available
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
United StatesSite Not Available
Neurological Associates of Albany
Albany, New York 12208
United StatesSite Not Available
Integrative Clinical Trials, LLC
Brooklyn, New York 11229
United StatesSite Not Available
Berman Clinical
New York, New York 10029
United StatesSite Not Available
Manhattan Behavioral Medicine, LLC
New York, New York 10036
United StatesSite Not Available
University of Rochester-AD-CARE Program
Rochester, New York 14620
United StatesSite Not Available
ERG Clinical Research - New York, PLLC
Staten Island, New York 10312
United StatesSite Not Available
Atrium Health Department of Psychiatry
Charlotte, North Carolina 28211
United StatesSite Not Available
Duke Neurology Research
Durham, North Carolina 27705
United StatesSite Not Available
AMC Research, LLC
Matthews, North Carolina 28105
United StatesSite Not Available
Wake Research of Raleigh
Raleigh, North Carolina 27612
United StatesSite Not Available
Insight Clinical Trials, LLC
Beachwood, Ohio 44122
United StatesSite Not Available
Neurology Diagnostics
Dayton, Ohio 45459
United StatesSite Not Available
Neurobehavioral Clinical Research
N. Canton, Ohio 44720
United StatesSite Not Available
Neurobehavioral Clinical Research
North Canton, Ohio 44720
United StatesSite Not Available
Center for Cognitive Health
Portland, Oregon 97225
United StatesSite Not Available
Summit Research Network Inc.
Portland, Oregon 97210
United StatesSite Not Available
Keystone Clinical Studies
Norristown, Pennsylvania 19462
United StatesSite Not Available
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island 02914
United StatesSite Not Available
WR-ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
Neurology Clinical, P.C.
Cordova, Tennessee 38018
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
Austin Clinical Trials Partners
Austin, Texas 78737
United StatesSite Not Available
Senior Adults Specialty Research
Austin, Texas 98757
United StatesSite Not Available
Kerwin Memory Center
Dallas, Texas 75231
United StatesSite Not Available
EI FARO Health and Therapeutics
Rio Grande City, Texas 78582
United StatesSite Not Available
Grayline Research Center
Wichita Falls, Texas 76309
United StatesSite Not Available
Next Stage Clinical Research
Woodway, Texas 76712
United StatesSite Not Available
Pantheon Clinical
Bountiful, Utah 84010
United StatesSite Not Available
University of Utah, Department of Neurology-Alzheimer's Disease Research
Salt Lake City, Utah 84108
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington 98201
United StatesSite Not Available
Swedish Neuroscience Research
Seattle, Washington 98122
United StatesSite Not Available
Northwest Neurological
Spokane, Washington 99202
United StatesSite Not Available
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