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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06874621 | VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease | PHASE1 | ACTIVE NOT_RECRUITING | 52 | — | — | Mar 3, 2025 | May 1, 2027 | Nov 19, 2025 | 23 | United States, Canada |
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline
| Arm | Type | Description |
|---|---|---|
| Cohort 1 active | EXPERIMENTAL | Low dose VY7523 |
| Cohort 1 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 1 active dose |
| Cohort 2 active | EXPERIMENTAL | mid dose VY7523 |
| Cohort 2 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 2 active dose |
| Cohort 3 active | EXPERIMENTAL | high dose VY7523 |
| Cohort 3 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 3 active dose |
| Name | Type | Description |
|---|---|---|
| VY7523 | DRUG | VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau |
| Placebo Comparator | DRUG | Matching placebo to VY7523 |
Inclusion Criteria: 1. Clinical diagnosis of early AD, defined as: 1. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD. 2. Mini Mental State Examination (MMSE) score between 18 and 30, inclusive, at Screening (Cohort 1 and 2) and score between 22 and 30, inclusive, at Scre...