Table 1.
Baseline demographics and characteristics of patients with Alzheimer's disease (first-in-human trial with UB-311 vaccine)
| Baseline demographics and disease assessment∗ | Value |
|---|---|
| Age, years | |
| Mean (SD) | 64.0 (8.3) |
| Median (range) | 64.0 (51.0–78.0) |
| Gender | |
| Male (%) | 9 (47.4) |
| Female (%) | 10 (52.6) |
| Race | |
| Asian (%) | 19 (100.0) |
| Other (%) | 0 (0.0) |
| BMI, kg/m2 | |
| Mean (SD) | 23.1 (2.1) |
| Median (range) | 22.6 (20.0–27.2) |
| Time since Alzheimer's disease diagnosis, years | |
| Mean (SD) | 2.4 (2.3) |
| Median (range) | 2.0 (0.3–10.7) |
| ADCS-CGIC | |
| Borderline (%) | 5 (26.3) |
| Mild (%) | 11 (57.9) |
| Moderate (%) | 3 (15.8) |
| MMSE | |
| Mean (SD) | 19.2 (3.2) |
| Median (range) | 19.0 (15.0–25.0) |
| HIS | |
| Mean (SD) | 1.4 (1.2) |
| Median (range) | 1.0 (0.0–4.0) |
| CDR | |
| Mean (SD) | 1.1 (0.3) |
| Median (range) | 1.0 (1.0–2.0) |
Abbreviations: SD, standard deviation; BMI, body mass index; ADCS-CGIC, Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change; MMSE, Mini–Mental State Examination; HIS, Hachinski Ischemic Score; CDR, Clinical Dementia Rating.
The enrolled patients were free of psychiatric, medical or substance abuse problems, history of severe systemic, autoimmune disease or anaphylaxis, hepatic insufficiency, poor control of blood sugar, positive human immunodeficiency virus, hepatitis C virus antibodies, or hepatitis B surface antigen enzyme immunoassay test results. Patients receiving stable treatment with cholinesterase inhibitors were not excluded from the trial.