12 completed, 2 terminated. 10 Phase 1, 3 Phase 2, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 2 | 3 | Terminated 2, Completed 1 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Terminated 1 |
Follow atabecestat: new trials by email Literature Review of atabecestat trials Research Report on atabecestat
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 |
|---|---|---|---|---|---|---|
| Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat) Atabecestat - Alzheimer Disease | Early Phase 1 | Completed | Janssen Research & Development, LLC | 9 | 2018-05-30 | 2025-04-27 |
| A Pharmacokinetic Interaction Study Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin in Healthy Participants Rosuvastatin, JNJ-54861911, Metformin - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 32 | 2016-04-05 | 2025-02-03 |
| An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia Atabecestat, 5 mg, Atabecestat, 25 mg, Placebo - Asymptomatic Amyloid-positive | Phase 2 / Phase 3 | Terminated | Janssen Research & Development, LLC | 557 | 2015-10-29 | 2025-04-29 |
| An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum JNJ-54861911, 10 mg, JNJ-54861911, 25 mg, Placebo - Alzheimer Disease | Phase 2 | Terminated | Janssen Research & Development, LLC | 90 | 2015-07-02 | 2025-04-29 |
| Study Investigating the Effects of JNJ-54861911 on Amyloid-beta Processing in Cerebrospinal Fluid (CSF) and Plasma in Japanese Participants Asymptomatic at Risk for Alzheimer Dementia JNJ-54861911, 10 mg, JNJ-54861911, 50 mg, Placebo - Alzheimer's Disease | Phase 1 | Completed | Janssen Pharmaceutical K.K. | 18 | 2015-02-16 | 2019-02-04 |
| A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B), JNJ-54861911 (Treatment C) - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 12 | 2015-01-01 | 2017-03-03 |
| A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease JNJ-54861911, 10 milligram (mg), JNJ-54861911, 50 mg, Placebo - Alzheimer's Disease | Phase 2 | Completed | Janssen Research & Development, LLC | 114 | 2014-11-01 | 2025-04-29 |
| A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates JNJ-54861911, Caffeine, Midazolam - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 16 | 2014-09-01 | 2015-11-24 |
| A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants JNJ-54861911, 25 mg, Itraconazole 200 mg, Clarithromycin 500 mg - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 13 | 2014-07-01 | 2014-10-15 |
| A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male Participants JNJ-54861911 (25 mg), JNJ-54861911 (50 mg), JNJ-54861911 (100 mg) - Healthy | Phase 1 | Completed | Janssen Pharmaceutical K.K. | 24 | 2014-06-01 | 2014-09-12 |
| A Study to Evaluate the Effects of JNJ-54861911 on Amyloid Beta Processing in Cerebrospinal Fluid and Plasma in Patients With Prodromal Alzheimer's Disease JNJ-54861911 10 mg, JNJ-54861911 50 mg, Placebo - Alzheimer Disease | Phase 1 | Completed | Janssen Research & Development, LLC | 45 | 2013-12-01 | 2015-06-25 |
| A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B), JNJ-54861911 (Treatment C) - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 12 | 2013-09-01 | 2014-10-09 |
| A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly Participants JNJ-54861911 3 mg, JNJ-54861911 10 mg, JNJ-54861911 30 mg - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 70 | 2013-05-01 | 2014-01-14 |
| A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With Placebo JNJ-54861911 1mg, JNJ-54861911 3 mg, JNJ-54861911 9 mg - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 56 | 2013-03-01 | 2014-11-10 |
Alzheimer Disease (12) · Dementia (1)
Janssen Research & Development, LLC (12) · Janssen Pharmaceutical K.K. (2)
Belgium (10) · Germany (5) · Netherlands (5) · Spain (5) · Sweden (5) · France (3) · Japan (3) · Australia (1) · Canada (1) · Denmark (1) · Finland (1) · Mexico (1) · United Kingdom (1) · United States (1)
PMID 30134967, PMID 32410694, PMID 33464300, PMID 39559869
2014 (5), 2015 (1), 2018 (1)