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Trial record 1 of 1 for:    ATH-1017-AD-0203
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Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04886063
Recruitment Status : Enrolling by invitation
First Posted : May 13, 2021
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Athira Pharma

Study Description
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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 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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 : January 2027
Estimated Study Completion Date : February 2027

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04886063


Locations
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Sponsors and Collaborators
Athira Pharma
More Information
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Responsible Party: Athira Pharma
ClinicalTrials.gov Identifier: NCT04886063    
Other Study ID Numbers: ATH-1017-AD-0203
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: February 2023

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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:
Alzheimer's
Dementia
ATH-1017
Open Label
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders