NCT04886063

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: LeonaBio · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	ATH-1017	Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2021-05-13
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study