Adults 55 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Primary· 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
Group
Value
95% CI
ATH-1017 40 Milligrams (mg)
323
ATH-1017 40 Milligrams (mg)
100
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 173 weeks; the protocolled 206-week treatment duration ended early due to study termination..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04831281 — ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
· Phase 2
· terminated
NCT04491006 — A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
· Phase 2
· completed
NCT04488419 — ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
· Phase 2, PHASE3
· completed
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Other LeonaBio trials
Trials by the same sponsor.
NCT06432647 — A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
· Phase 1
· completed
NCT05511558 — A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
· Phase 1
· completed
NCT05169671 — Safety, Tolerability, and Pharmacokinetics Study of ATH-1020
· Phase 1
· completed
NCT04831281 — ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
· Phase 2
· terminated
NCT04491006 — A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LeonaBio
Last refreshed: 1 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04886063.