Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XPro1595 · 2 trials · 10 indications
Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency \[D-KEFS\]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement.
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...
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