6 completed, 2 terminated, 1 recruiting. 4 Phase 1, 4 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 4 | Completed 2, Terminated 2 |
| Phase 3 | 3 | Completed 1, Recruiting 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105 ATH-1105, Placebo - Healthy Volunteers | Phase 1 | Completed | LeonaBio | 80 | 2024-04-24 | 2025-01-23 |
| Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib - Metastatic Breast Cancer | Phase 3 | Recruiting | LeonaBio | 600 | 2023-10-31 | 2026-06-22 |
| A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) [14C]-Fosgonimeton - Healthy Volunteers | Phase 1 | Completed | LeonaBio | 8 | 2022-07-13 | 2022-12-22 |
| Safety, Tolerability, and Pharmacokinetics Study of ATH-1020 ATH-1020, Placebo - Healthy Volunteers | Phase 1 | Completed | LeonaBio | 32 | 2022-03-30 | 2024-04-08 |
| ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial) ATH-1017, Placebo - Parkinson Disease Dementia, Dementia With Lewy Bodies | Phase 2 | Terminated | LeonaBio | 28 | 2022-01-20 | 2025-03-04 |
| Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease ATH-1017 - Alzheimer Disease | Phase 2 / Phase 3 | Terminated | LeonaBio | 423 | 2021-06-30 | 2025-04-01 |
| A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease ATH-1017, Placebo - Alzheimer Disease, Dementia of Alzheimer Type | Phase 2 | Completed | LeonaBio | 77 | 2020-11-23 | 2023-06-12 |
| ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease ATH-1017, Placebo - Alzheimer Disease, Dementia of Alzheimer Type | Phase 2 / Phase 3 | Completed | LeonaBio | 554 | 2020-09-28 | 2025-04-04 |
| Safety, Tolerability, and Pharmacokinetics Study of NDX-1017 NDX-1017, Placebo - Alzheimer Disease | Phase 1 | Completed | LeonaBio | 88 | 2017-10-09 | 2019-09-10 |
Dementia (5) · Alzheimer Disease (4) · Brain Diseases (1) · Breast Neoplasms (1) · Central Nervous System Diseases (1) · Deafness, Autosomal Recessive 39 (1) · Lewy Body Disease (1) · Memory Disorders (1) · Mental Disorders (1) · Neurocognitive Disorders (1) · Neurodegenerative Diseases (1)
Fulvestrant (1) · Lasofoxifene (1) · abemaciclib (1)
United States (9) · Australia (2) · Belgium (1) · Canada (1) · China (1) · France (1) · Germany (1) · Israel (1) · Italy (1) · Poland (1) · Romania (1) · Singapore (1) · South Korea (1) · Spain (1) · Taiwan (1)
Javier San Martin, MD (1) · Xue Hua, PhD (1)
PMID 38599894, PMID 35180125, PMID 40222048
R01AG068268 (1)