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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05738486 | A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) | PHASE3 | ACTIVE NOT_RECRUITING | 1,175 | — | — | Feb 28, 2023 | May 1, 2027 | Nov 14, 2025 | 49 | United States, United Kingdom |
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
| Arm | Type | Description |
|---|---|---|
| 1400 mg Donanemab - Standard Regimen | EXPERIMENTAL | Participants received: * 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. * placebo administered IV at week 2, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. |
| 1400 mg Donanemab - Dose Skipping | EXPERIMENTAL | Participants received: * 700 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 4, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24. |
| 1400 mg Donanemab - Titration | EXPERIMENTAL | Participants received: * 350 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 6, 10, and 14. * 700 mg donanemab administered IV at week 4. * 1050 mg of donanemab administered IV at week 8. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. |
| 1400 mg Donanemab - Maximum Concentration (Cmax) | EXPERIMENTAL | Participants received: * 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. * 700 mg donanemab administered IV at weeks 12 and 14. * 1400 mg of donanemab administered IV at weeks 16, 20, and 24. |
| Donanemab Addendum Arm 1 | EXPERIMENTAL | Participants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion. |
| Donanemab Addendum Arm 2 | EXPERIMENTAL | Participants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion |
| Name | Type | Description |
|---|---|---|
| Donanemab | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| Dexamethasone | DRUG | Administered IV |
Inclusion Criteria: * Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. * A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening. * Have an amyloid PET scan result from central read, consistent with the presence of a...