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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04592874 | A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease | PHASE2 | COMPLETED | 356 | — | — | Jan 22, 2021 | Sep 12, 2024 | Oct 29, 2025 | 87 | United States, Argentina +10 |
Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.
| Arm | Type | Description |
|---|---|---|
| AL002 Dose 1 | EXPERIMENTAL | AL002 every 4 weeks |
| AL002 Dose 2 | EXPERIMENTAL | AL002 every 4 weeks |
| AL002 Dose 3 | EXPERIMENTAL | AL002 every 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo every 4 weeks |
| Name | Type | Description |
|---|---|---|
| AL002 | DRUG | Administered via intravenous (IV) infusion |
| Placebo | DRUG | Administered via intravenous (IV) infusion |
Inclusion Criteria: * Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET * MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95. * Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a...