NCT04488419

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

A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: LeonaBio · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.

Detailed description

The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.

Conditions

• Alzheimer Disease
• Dementia of Alzheimer Type

Interventions

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

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2020-07-28
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study