Table 1.
Baseline characteristics and demographics
| Characteristics and demographics | Double blind |
Extension |
AIBL |
||
|---|---|---|---|---|---|
| Placebo (n = 15) | PBT2 (n = 25) | Completers at 12 months (n = 27) | Withdrawals at 12 months (n = 13) | (n = 46) | |
| Age (years) | 72.1 (6.9) | 71.4 (10.1) | 71.1 (8.2) | 74.2 (11.0) | 75.0 (7.5) |
| Gender (M/F) | 11/4 | 11/14 | 15/12 | 7/6 | 28/18 |
| APOE ε4+ (%) | 10 (67) | 19 (76) | 21 (78) | 8 (62) | 37 (80) |
| Global SUVR | |||||
| Unadjusted | 2.48 (0.41) | 2.43 (0.36) | 2.26 (0.31)∗ | 2.64 (0.33)† | 2.46 (0.30) |
| Adjusted | 2.54 (0.65) | 2.48 (0.56) | 2.30 (0.47) | 2.68 (0.55)‡ | 2.50 (0.49) |
| FDG-PET§ | 0.90 (0.09) | 0.93 (0.07) | 0.89 (0.08) | 0.87 (0.07) | − |
| Hippocampal volume§ | 3.76 (0.53) | 3.88 (0.41) | 3.69 (0.48) | 3.75 (0.33) | 3.57 (0.44) |
| Gray matter volume§ | 244.9 (19.0) | 246.3 (19.7) | 242.4 (24.3) | 237.9 (13.3) | N/A |
| Ventricular volume§ | 29.4 (10.0) | 29.0 (12.2) | 31.0 (10.8) | 34.3 (15.4) | 29.7 (11.0) |
| Blood plasma§ Aβ40 | 182.4 (23.5) | 192.1 (35.0) | 174.7 (32.2) | 178.3 (30.6) | N/A |
| Aβ42 | 38.4 (8.4) | 40.7 (10.3) | 39.5 (10.3) | 40.4 (6.4) | N/A |
| Aβ monomer | 27.6 (12.6) | 25.6 (17.3) | 14.7 (7.2) | 17.0 (8.6) | N/A |
| Aβ dimer | 135.8 (81.8) | 131.5 (110.3) | 69.1 (38.3) | 90.6 (49.1) | N/A |
| Cognition | |||||
| MMSE | 25.2 (2.2) | 23.6 (2.5) | 24.4 (2.4) | 23.8 (2.8) | 24.6 (2.8) |
| Main composite | 0.19 (0.7) | −0.07 (0.7) | 0.05 (0.8) | −0.32 (0.7) | N/A |
| Memory composite | 0.40 (1.1) | −0.18 (0.9) | −0.02 (1.1) | −0.34 (0.9) | N/A |
| Executive function composite | 0.08 (0.7) | −0.02 (0.8) | 0.08 (0.7) | −0.33 (90.8) | N/A |
| ADCS-ADL-23 | 64.4 (8.4) | 67.4 (8.7) | 64.5 (9.4) | 62.6 (13.0) | N/A |
NOTE. Data are mean (standard deviation) or N (%).
Abbreviations: AIBL, Australian Imaging Biomarker and Lifestyle Study; APOE, apolipoprotein E; SUVR, standardized uptake volume ratio; FDG-PET, fluorodeoxyglucose-positron emission tomography; Aβ, amyloid β; MMSE, Mini–Mental State Examination; ADCS-ADL, Alzheimer's Disease Cooperative Study–Activities of Daily Living; N/A, data not available.
∗
P < .05.
†
P < .001 (compared to completers at 12 months).
‡
P < .0001 (compared to completers at 12 months).
§
All values adjusted for baseline.