Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03587376 | Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat) | EARLY_PHASE1 | COMPLETED | 9 | — | — | May 30, 2018 | Aug 23, 2018 | Apr 27, 2025 | 5 | Belgium, France +3 |
Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response (via cluster of differentiation \[CD\] 4+ T-cells and CD8+ T-cells) will be determined.
| Arm | Type | Description |
|---|---|---|
| Participants with Elevated Liver Enzymes | EXPERIMENTAL | Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat. |
| Participants Without Elevated Liver Enzymes | ACTIVE_COMPARATOR | Blood samples will be collected on Day 1 from participants who completed at least 3 months of dosing with atabecestat and who did not have the elevated liver enzymes (adverse event) while on atabecestat. |
| Name | Type | Description |
|---|---|---|
| Atabecestat | DRUG | Blood samples will be collected from participants previously treated with atabecestat. |
Inclusion Criteria: * Participant who received and discontinued atabecestat in one of the following prior trials (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004) * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the s...