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

August 17, 2023 updated by: Athira Pharma

Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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 30 months in subjects with mild to moderate Alzheimer's disease.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Centre for Applied Medical Research, Translational Research Centre
      • Greenwich, New South Wales, Australia, 2065
        • HammondCare Greenwich Hospital
      • Macquarie Park, New South Wales, Australia, 2113
        • KaRa MINDS
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • HammondCare
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Australian Alzheimer's Research Organization
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
    • Colorado
      • Denver, Colorado, United States, 80218
        • Mile High Research Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of SW Florida
      • Maitland, Florida, United States, 32751
        • ClinCloud
      • Merritt Island, Florida, United States, 32952
        • Merrit Island Medical Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Savannah, Georgia, United States, 31405
        • iResearch Savannah
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience, Memory Disorders Center & Alzheimer's Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimer's Disease Center, Rush University Medical Center
      • Springfield, Illinois, United States, 62702
        • SIU Medicine Neuroscience Institute (NSI)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Neuroscience Center
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital
      • Lowell, Massachusetts, United States, 01852
        • ActivMed Practices & Research, Inc.
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Lou Ruvo Center for Brain Health
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Hackensack University Medical Center
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes LLC; Princeton Medical Institute
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Institute of NJ
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine, PLLC
      • Rochester, New York, United States, 14620
        • University of Rochester-AD-CARE Program
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Atrium Health Department of Psychiatry
      • Durham, North Carolina, United States, 27705
        • Duke Neurology Research
      • Matthews, North Carolina, United States, 28105
        • AMC Research, LLC
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Insight Clinical Trials, LLC
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnostics
      • North Canton, Ohio, United States, 44720
        • Neurobehavioral Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97225
        • Center for Cognitive Health
      • Portland, Oregon, United States, 97210
        • Summit Research Network Inc.
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19462
        • Keystone Clinical Studies
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Mood & Memory Research Institute
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinical, P.C.
    • Texas
      • Austin, Texas, United States, 98757
        • Senior Adults Specialty Research
      • Wichita Falls, Texas, United States, 76309
        • Grayline Research Center
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98034
        • Evergreen Health Research Program
      • Seattle, Washington, United States, 98104
        • University of Washington
      • Spokane, Washington, United States, 99202
        • Northwest Neurological

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 accept responsibility for supervising the daily treatment or, if required, administering study drug.
  • Subject capable of giving signed informed consent, or by a legally acceptable representative.
  • Subjects must be in generally good health.
  • Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.

Exclusion Criteria:

  • Subject has experienced a serious adverse event during the parent study, which could present 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 stable in the judgement of the investigator:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 130 Weeks
Description - To determine the safety and tolerability of ATH-1017 over an additional 130-week period in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202
130 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athira Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATH-1017-AD-0203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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