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NCT04886063 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by LeonaBio.

Terminated
Registry status
Phase 2
Development phase
423
Enrollment target

NCT04886063: Clinical Trial Phase 2 study, sponsored by LeonaBio.

NCT04886063 is a Phase 2 study that was terminated before completion, run by LeonaBio. The registered enrollment target is 423 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (218% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04886063, a Phase 2 study, was terminated before completion, sponsored by LeonaBio.

TERMINATED
Registry status
Phase 2
Development phase
423 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG ATH-1017

Trial Details

FieldValue
Enrollment Target 423 participants
Start Date 2021-06-30
Est. Completion 2024-10-23
Phase Phase 2
LeonaBio

8 total trials

Why NCT04886063 stopped before completion

NCT04886063 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (218% higher).

The record links to 0 conditions, and to 1 intervention - of which ATH-1017 is the first listed.

NCT04886063 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04886063 about?

NCT04886063 is a clinical study titled "Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease". 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.

What is the current status of trial NCT04886063?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 423 participants. The study started on 2021-06-30. Estimated completion is 2024-10-23.

What interventions are being tested in trial NCT04886063?

The interventions under investigation include: ATH-1017 (DRUG).

Who is sponsoring clinical trial NCT04886063?

This trial is sponsored by LeonaBio, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04886063's enrollment target sits among peer trials

423 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04886063, the US trial registry maintained by the National Library of Medicine. NCT04886063 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.