6 completed, 3 terminated. 3 Phase 1, 3 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 3 | Terminated 2, Completed 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 Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function Simufilam - Hepatic Insufficiency | Phase 1 | Completed | Cassava Sciences, Inc. | 27 | 2024-06-26 | 2025-01-07 |
| Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects Simufilam - Absorption, Metabolism | Phase 1 | Completed | Cassava Sciences, Inc. | 8 | 2024-02-07 | 2025-03-20 |
| Open-label Extension for Phase 3 Clinical Trials of Simufilam Simufilam - Alzheimer Disease | Phase 3 | Terminated | Cassava Sciences, Inc. | 1081 | 2022-11-07 | 2025-05-23 |
| Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease simufilam - Alzheimer's Disease | Phase 2 | Terminated | Cassava Sciences, Inc. | 90 | 2022-05-12 | 2025-08-15 |
| Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease Simufilam, Placebo - Alzheimer Disease | Phase 3 | Terminated | Cassava Sciences, Inc. | 1125 | 2021-11-18 | 2025-09-22 |
| Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease Simufilam, Placebo - Alzheimer Disease | Phase 3 | Completed | Cassava Sciences, Inc. | 804 | 2021-11-03 | 2025-05-25 |
| Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers simufilam - Healthy Volunteers | Phase 1 | Completed | Cassava Sciences, Inc. | 24 | 2021-05-04 | 2023-08-22 |
| Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients Simufilam 100 mg oral tablet, Placebo - Alzheimer Disease | Phase 2 | Completed | Cassava Sciences, Inc. | 220 | 2020-03-24 | 2025-04-22 |
| PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Placebo oral tablet, Simufilam 100 mg tablet, Simufilam 50 mg oral tablet - Alzheimer Disease | Phase 2 | Completed | Cassava Sciences, Inc. | 64 | 2019-09-09 | 2021-09-29 |
Alzheimer Disease (6) · Hepatic Insufficiency (1)
United States (9) · Canada (5) · Australia (2) · Puerto Rico (2) · South Korea (2)
James Kupiec, MD (3) · Lindsay Burns, PhD (2) · Chris Cook, JD (1) · Robert G Bass, MD (1)
PMID 41500915, PMID 33188449, PMID 36934371
R44AG060878 (1), R44AG065152 (1)