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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06489548 | Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease | PHASE2 | RECRUITING | 16 | — | — | Sep 16, 2025 | Dec 1, 2026 | Feb 12, 2026 | 1 | United States |
Establish the safety and tolerability of nasal foralumab dosing in subjects as a percentage of drug and placebo groups who experience adverse events.
The ligand \[18F\]PBR06 provides a quantification of microglial activation during a PET scan. The investigatorshope to use this tracer at the start and end of the study to examine how the use of Foralumab may affect microglial function.
| Arm | Type | Description |
|---|---|---|
| Arm A: This cohort of subjects will receive 100µg/dosing day vs. placebo throughout the study. | ACTIVE_COMPARATOR | This group will receive a nasal spray three times a week for two weeks, followed by a one-week rest. That cycle will occur three more times for a total of three months of drug intervention. |
| Arm B: This cohort of subjects will receive 50µg/dosing day vs. placebo throughout the study. | ACTIVE_COMPARATOR | This group will receive a nasal spray three times a week for two weeks, followed by a one-week rest. That cycle will occur three more times for a total of three months of drug intervention. |
| Name | Type | Description |
|---|---|---|
| Foralumab TZLS-401 50 µg | DRUG | Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 50 µg vs. placebo. |
| Foralumab TZLS-401 100 µg | DRUG | Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 100 µg vs. placebo. |
Inclusion Criteria: 1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines for Early Symptomatic Alzheimer's Disease (AD) with a 20-30 MMSE score, Clinical Dementia Rating (CDR) global score of 0.5 or 1, and impaired memory performance below an education adjusted cut-off score...