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

Phase 2

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: ATH-1017

• Registration Number: NCT04886063
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-13
• Study Start: 2021-06-30
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Status Verified: 2025-03
• Results First Submitted: 2025-03-12
• Results First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Results First Posted: 2025-04-01
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 423

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	ATH-1017	Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 173 weeks (study termination)	Description - To determine the safety and tolerability of ATH-1017 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

Trial Locations

Locations (1)

University of Rochester-AD-CARE Program; 🇺🇸 Rochester, New York, United States