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

Last updated: March 31, 2025
Sponsor: Athira Pharma
Overall Status: Terminated

Phase

2/3

Condition

N/A

Treatment

ATH-1017

Clinical Study ID

NCT04886063
ATH-1017-AD-0203
  • Ages 55-85
  • All Genders

Study Summary

The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).

  • Reliable and capable support person/caregiver who is willing to acceptresponsibility for supervising the daily treatment or, if required, administeringstudy drug.

  • Subject capable of giving signed informed consent, or by a legally acceptablerepresentative.

  • Subjects must be in generally good health.

  • Male subjects and their partners must agree to continue to use a double-barriermethod of contraception during the study, including the follow-up period, unless thepartner is not of childbearing potential.

Exclusion

Exclusion Criteria:

  • Subject has experienced a serious adverse event during the parent study, which couldpresent an increased safety risk during the open label extension.

  • New diagnosis of severe major depressive disorder even without psychotic features.

  • Any subject with formalized delusions or hallucinations.

  • Significant suicide risk.

  • Newly-diagnosed malignant tumor, except for the following conditions that are stablein the judgement of the investigator:

  • Adequately treated squamous and basal cell carcinoma, or squamous and basalcell carcinoma in situ

  • Prostate carcinoma in situ

Study Design

Total Participants: 423
Treatment Group(s): 1
Primary Treatment: ATH-1017
Phase: 2/3
Study Start date:
June 30, 2021
Estimated Completion Date:
October 23, 2024

Study Description

This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.

Connect with a study center

  • St Vincent's Centre for Applied Medical Research, Translational Research Centre

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Hammondcare Greenwich Hospital

    Greenwich, New South Wales 2065
    Australia

    Site Not Available

  • KaRa MINDS

    Macquarie Park, New South Wales 2113
    Australia

    Site Not Available

  • HammondCare

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Australian Alzheimer's Research Organization

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • 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

  • Neurology Center of North Orange County

    Fullerton, California 92835
    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

  • Denver Neurological

    Denver, Colorado 80210
    United States

    Site Not Available

  • Mile High Research Center

    Denver, Colorado 80218
    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

  • JEM Research Institute

    Lake Worth, Florida 33462
    United States

    Site Not Available

  • Accel Clinical Research

    Largo, Florida 33777
    United States

    Site Not Available

  • ClinCloud

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merrit Island Medical Research

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Global Medical Institutes LLC

    Miami, Florida 33125
    United States

    Site Not Available

  • Mart Medical Group Research

    Miami, Florida 33166
    United States

    Site Not Available

  • Optimus U Corp

    Miami, Florida 33125
    United States

    Site Not Available

  • Quantix Research

    Miami, Florida 33173
    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

  • 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 Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel

    Savannah, Georgia 31405
    United States

    Site Not Available

  • iResearch Savannah

    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 62702
    United States

    Site Not Available

  • IU Health Neuroscience Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Northern Light Acadia Hospital

    Bangor, Maine 04401
    United States

    Site Not Available

  • Headlands PharmaSite

    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

  • 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

  • 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

    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

  • Manhattan Behavioral Medicine, PLLC

    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

    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

  • 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

  • Neurology Clinical, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee 38119
    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

  • El 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

  • 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

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Evergreen Health Research Program

    Kirkland, Washington 98034
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98104
    United States

    Site Not Available

  • Northwest Neurological

    Spokane, Washington 99202
    United States

    Site Not Available

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