Table 3 Adverse events (>2% of patients overall) from a phase 2a study of ACC-001 in Japanese patients with mild-to-moderate Alzheimer’s disease[28]
Event | ACC-001 + QS-21 | ACC-001 | QS-21 (n = 6) | PBS (n = 4) | |||
|---|---|---|---|---|---|---|---|
3 μg (n = 6) | 10 μg (n = 6) | 30 μg (n = 6) | 10 μg (n = 6) | 30 μg (n = 6) | |||
Any serious adverse eventa | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 0 | 0 |
Any adverse events | 6 (100.0) | 4 (66.7) | 5 (83.3) | 6 (100.0) | 6 (100.0) | 6 (100.0) | 3 (75.0) |
Nasopharyngitis | 2 (33.3) | 2 (33.3) | 2 (33.3) | 0 | 3 (50.0) | 1 (16.7) | 2 (50.0) |
Injection site erythema | 0 | 2 (33.3) | 0 | 0 | 1 (16.7) | 0 | 0 |
Dental caries | 0 | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) | 0 | 1 (25.0) |
Protein urine present | 1 (16.7) | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 |
Glucose urine | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (25.0) |
Cataract | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 | 1 (25.0) |
Contusion | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 |
Back pain | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 |
Blood triglyceride increased | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 |
Injection site pain | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 0 |
Pyrexia | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 |
Delirium | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (16.7) | 0 |
Blood pressure increased | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 |
Eczema | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (25.0) |