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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04408625 | Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) | PHASE1 | ACTIVE NOT_RECRUITING | 35 | — | — | Nov 9, 2020 | Nov 30, 2029 | Apr 30, 2026 | 12 | United States, Australia +4 |
Measured by brain and spine MRI
PGRN: progranulin protein. Measured by level of antibodies and ELISPOT
Measured by levels of antibodies.
| Arm | Type | Description |
|---|---|---|
| Initial Cohort - Low dose | EXPERIMENTAL | - |
| Initial Cohort - Medium dose | EXPERIMENTAL | - |
| Bridging Cohort - Low dose | EXPERIMENTAL | Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner |
| Bridging Cohort - Medium dose | EXPERIMENTAL | Participants enrolled in the Bridging Cohort will be assigned to either low or medium dose in an alternating manner |
| Cohort 5-Medium Dose | EXPERIMENTAL | Will enroll up to 10 participants with early phase of disease |
| Name | Type | Description |
|---|---|---|
| LY3884963 | BIOLOGICAL | Participants will receive a single dose of LY3884963, administered intra cisterna magna |
| Methylprednisolone | DRUG | IV pulses every 2 weeks in the first 3 months. |
| Optional Sirolimus | DRUG | At the investigators discretion following steroid tolerability issues, patients may receive a loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication |
| Optional Prednisone | DRUG | If needed and at the investigator discretion, Oral Prednisone may be added to the immunosuppression regimen |
Inclusion Criteria: * Men or women aged 30 to 85 years (inclusive), at the time of informed consent. * Body weight range of ≥40 kg (88 lbs) to ≤110 kg (242 lb) and a BMI of 18 to 34 kg/m2. * Has symptomatic frontotemporal dementia (FTD), including mild behavioral, cognitive, motor or language impai...