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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06544616 | A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease | PHASE2 | ACTIVE NOT_RECRUITING | 55 | — | — | Jul 22, 2024 | Jan 5, 2027 | Jun 5, 2026 | 90 | United States, Australia +7 |
Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-64042056 | EXPERIMENTAL | Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76. |
| Arm B: Placebo | PLACEBO_COMPARATOR | Participants will receive IM injection of placebo from Week 0 up to a maximum of Week 76. |
| Name | Type | Description |
|---|---|---|
| JNJ-64042056 | DRUG | JNJ-64042056 will be administered intramuscularly. |
| Placebo | DRUG | Placebo will be administered intramuscularly. |
Inclusion Criteria: * Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease...