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

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

Tracking Information

• First Submitted Date: May 10, 2021
• First Posted Date: May 13, 2021
• Last Update Posted Date: August 21, 2023
• Actual Study Start Date: June 30, 2021
• Estimated Primary Completion Date: January 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2023)

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

Original Primary Outcome Measures (submitted: May 10, 2021)

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
• 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
• 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.
• 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
• Study Phase: Phase 2; Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open label extension

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Alzheimer Disease

Intervention

Drug: ATH-1017

Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Study Arms

Experimental: Treatment

Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage

Intervention: Drug: ATH-1017

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 15, 2023): 450
• Original Estimated Enrollment (submitted: May 10, 2021): 300
• Estimated Study Completion Date: February 2027
• Estimated Primary Completion Date: January 2027 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, United States

Administrative Information

• NCT Number: NCT04886063
• Other Study ID Numbers: ATH-1017-AD-0203
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Athira Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: Athira Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Athira Pharma
• Verification Date: February 2023