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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05318976 | A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation | PHASE2 | COMPLETED | 208 | — | — | Feb 28, 2022 | May 12, 2025 | Mar 27, 2026 | 41 | Australia, Canada +6 |
| NCT03943264 | A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's | PHASE1 | COMPLETED | 20 | — | — | Nov 20, 2019 | Sep 1, 2021 | Jun 15, 2023 | 5 | Australia |
Change in the Early and Mild Alzheimer's cognitive composite (EMACC) from Baseline to Week 24 in the following assessments: * International Shopping List Test-Immediate recall (Word List learning Test) * Digit Span Forward and Backward * Category Fluency Test (DKEFS) * Letter Fluency Test (DKEFS) * Trail Making Test Parts A and B * Digit Symbol Coding Test To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi
Adverse events will be assessed by clinical and laboratory measures
Adverse events will be assessed by clinical and laboratory measures
| Arm | Type | Description |
|---|---|---|
| 1.0 mg/kg XPro1595 | EXPERIMENTAL | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. |
| 1.0 mg/kg Placebo | PLACEBO_COMPARATOR | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. |
| 0.3 mg/kg XPro1595 | EXPERIMENTAL | 0.3 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| 0.6 mg/kg XPro1595 | EXPERIMENTAL | 0.6 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| XPro1595 | DRUG | XPro1595 will be delivered by subcutaneous injection once a week |
| Placebo | DRUG | Placebo will be delivered by subcutaneous injection once a week |
The screening window for this trial is 45 days. Inclusion Criteria: To be eligible for study entry, patients must satisfy all of the following criteria: * Adult patients 50 years to ≤ 85 years of age at the time of consent; * Meets the diagnostic criteria of MCI of probable Alzheimer's disease (J...