4 completed, 1 recruiting, 1 terminated. 3 Phase 1, 2 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 2, Recruiting 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 2 | 1 | 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 |
|---|---|---|---|---|---|---|
| Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults ALZ-507, Placebo - Healthy Participants Study | Phase 1 | Recruiting | Alzheon Inc. | 84 | 2026-03-09 | 2026-09-17 |
| Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects Experimental: ALZ-801 - Early Alzheimer's Disease | Phase 3 | Terminated | Alzheon Inc. | 163 | 2024-04-02 | 2026-06-25 |
| An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects Experimental: ALZ-801, Placebo Comparator: Placebo - Early Alzheimer's Disease | Phase 3 | Completed | Alzheon Inc. | 325 | 2021-05-19 | 2026-09-29 |
| Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease ALZ-801 - Early Alzheimer's Disease | Phase 2 | Completed | Alzheon Inc. | 84 | 2020-09-30 | 2025-12-18 |
| Multiple Ascending Dose Study of ALZ-801 ALZ-801 or matching placebo - Alzheimer Disease | Phase 1 | Completed | Alzheon Inc. | 48 | 2015-09-26 | 2019-11-19 |
| Single Dose Study of ALZ-801 Prototype Tablets ALZ-801 170 mg Fasting, ALZ-801 205 mg Fasting, ALZ-801 205 mg After Food - Alzheimer Disease | Phase 1 | Completed | Alzheon Inc. | 12 | 2015-09-16 | 2020-10-14 |
Alzheimer Disease (5) · Central Nervous System Diseases (1) · Dementia (1) · Mental Disorders (1) · Nervous System Diseases (1) · Neurocognitive Disorders (1) · Neurodegenerative Diseases (1) · Tauopathies (1)
ALZ-801 (3) · Postprandial Period (1)
United Kingdom (3) · United States (3) · Canada (2) · Czechia (2) · Netherlands (2) · France (1) · Germany (1) · Iceland (1) · Spain (1)
Susan Abushakra, MD (2) · Ann Church, PhD (1) · John Hey, PhD (1) · Pui Leung, MD (1)
PMID 29063518, PMID 42678603, PMID 38902571, PMID 38902572, PMID 39907966, PMID 41015981
R01AG065253 (1)