ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Last updated: April 3, 2025
Sponsor: Athira Pharma
Overall Status: Completed

Phase

2/3

Condition

Dementia

Treatment

ATH-1017

Placebo

Clinical Study ID

NCT04488419
ATH-1017-AD-0201
  • Ages 55-85
  • All Genders

Study Summary

This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.

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

Total Participants: 554
Treatment Group(s): 2
Primary Treatment: ATH-1017
Phase: 2/3
Study Start date:
September 28, 2020
Estimated Completion Date:
July 15, 2024

Study Description

The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Xenoscience

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • ATP Clinical Research, Inc

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Wr - Pri, Llc

    Encino, California 91316
    United States

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Sun Valley Research Center, Inc.

    Imperial, California 92251
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Sunwise Clinical Research

    Lafayette, California 94549
    United States

    Site Not Available

  • Healthy Brain Research Inc

    Long Beach, California 90804
    United States

    Site Not Available

  • PRI Research

    Los Alamitos, California 90720
    United States

    Site Not Available

  • PRI Research

    Newport Beach, California 92660
    United States

    Site Not Available

  • Pacific Research Network

    San Diego, California 92103
    United States

    Site Not Available

  • Southern California Research, LLC

    Simi Valley, California 93065
    United States

    Site Not Available

  • Viking Clinical

    Temecula, California 92591
    United States

    Site Not Available

  • Denver Neurological Research, LLC

    Denver, Colorado 80210
    United States

    Site Not Available

  • Mile High Research Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • CenExel RMCR

    Englewood, Colorado 80113
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Boynton Beach Medical Research Institute

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • K2 Medical Research Winter Garden

    Clermont, Florida 34711
    United States

    Site Not Available

  • Accel Clinical Research

    DeLand, Florida 32720
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of SW Florida

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Reliable Clinical Research LLC

    Hialeah, Florida 33012
    United States

    Site Not Available

  • K2 Medical Research-The Villages

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Wr-Msra, Llc

    Lake City, Florida 32055
    United States

    Site Not Available

  • JEM Research Institute

    Lake Worth, Florida 33462
    United States

    Site Not Available

  • ClinCloud

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Global Medical Institutes, LLC dba South Miami Medical Institute

    Miami, Florida 33125
    United States

    Site Not Available

  • Innova Pharma

    Miami, Florida 33175
    United States

    Site Not Available

  • Optimus U Corp

    Miami, Florida 33125
    United States

    Site Not Available

  • Quantix Research

    Miami, Florida 33155
    United States

    Site Not Available

  • K2 Medical Research Maitland

    Orlando, Florida 32751
    United States

    Site Not Available

  • Accel Clinical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Accel Clinical Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Mart Medical Group Research

    South Miami, Florida 33143
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Accel Clinical Research

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Rush Alzheimer's Disease Center, Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • SIU Medicine Neuroscience Institute (NSI)

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Indiana University School of Medicine, Department of Neurology

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Ochsner Clinical Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Northern Light Acadia Hospital

    Bangor, Maine 04401
    United States

    Site Not Available

  • PharmaSite Research

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Massachusetts General Hospital

    Charlestown, Massachusetts 02129
    United States

    Site Not Available

  • Activmed Practices & Research, Inc.

    Lowell, Massachusetts 01852
    United States

    Site Not Available

  • Boston Center for Memory

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • M3 Wake Research

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Hackensack Meridian Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Global Medical Institutes LLC; Princeton Medical Institute

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Neurological Associates of Albany

    Albany, New York 12208
    United States

    Site Not Available

  • Integrative Clinical Trials, LLC

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Berman Clinical

    New York, New York 10029
    United States

    Site Not Available

  • Manhattan Behavioral Medicine, LLC

    New York, New York 10036
    United States

    Site Not Available

  • University of Rochester-AD-CARE Program

    Rochester, New York 14620
    United States

    Site Not Available

  • ERG Clinical Research - New York, PLLC

    Staten Island, New York 10312
    United States

    Site Not Available

  • Atrium Health Department of Psychiatry

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Duke Neurology Research

    Durham, North Carolina 27705
    United States

    Site Not Available

  • AMC Research, LLC

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Wake Research of Raleigh

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Insight Clinical Trials, LLC

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Neurology Diagnostics

    Dayton, Ohio 45459
    United States

    Site Not Available

  • Neurobehavioral Clinical Research

    N. Canton, Ohio 44720
    United States

    Site Not Available

  • Neurobehavioral Clinical Research

    North Canton, Ohio 44720
    United States

    Site Not Available

  • Center for Cognitive Health

    Portland, Oregon 97225
    United States

    Site Not Available

  • Summit Research Network Inc.

    Portland, Oregon 97210
    United States

    Site Not Available

  • Keystone Clinical Studies

    Norristown, Pennsylvania 19462
    United States

    Site Not Available

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Neurology Clinical, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Austin Clinical Trials Partners

    Austin, Texas 78737
    United States

    Site Not Available

  • Senior Adults Specialty Research

    Austin, Texas 98757
    United States

    Site Not Available

  • Kerwin Memory Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • EI FARO Health and Therapeutics

    Rio Grande City, Texas 78582
    United States

    Site Not Available

  • Grayline Research Center

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Next Stage Clinical Research

    Woodway, Texas 76712
    United States

    Site Not Available

  • Pantheon Clinical

    Bountiful, Utah 84010
    United States

    Site Not Available

  • University of Utah, Department of Neurology-Alzheimer's Disease Research

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Swedish Neuroscience Research

    Seattle, Washington 98122
    United States

    Site Not Available

  • Northwest Neurological

    Spokane, Washington 99202
    United States

    Site Not Available

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