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Trial record 1 of 4 for:    ATH-1017 | Alzheimer Disease
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Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04886063
Recruitment Status : Enrolling by invitation
First Posted : May 13, 2021
Last Update Posted : March 14, 2022
Information provided by (Responsible Party):
Athira Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: ATH-1017 Phase 2

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 one year in total in subjects with mild to moderate Alzheimer's disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label extension
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Daily subcutaneous (SC) injection of ATH-1017
Drug: ATH-1017
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 26 Weeks ]
    Safety and tolerability of ATH-1017 as measured by clinical laboratory measures, vital signs, and physical and neurological exams.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04886063

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Sponsors and Collaborators
Athira Pharma
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Responsible Party: Athira Pharma Identifier: NCT04886063    
Other Study ID Numbers: ATH-1017-AD-0203
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athira Pharma:
Open Label
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders