Table 1.
Demographics and baseline characteristics.
| As treated | As randomized | |||||||
|---|---|---|---|---|---|---|---|---|
| Characteristic | Sham | Active | Overall | P-value | Sham | Active | Overall | P-value |
| Age | ||||||||
| N | 27 | 43 | 70 | 0.0092 | 28 | 42 | 70 | 0.0133 |
| Mean (SD) | 75.6 (10.04) | 69.7 (7.99) | 72.0 (9.21) | 75.3 (9.95) | 69.8 (8.08) | 72.0 (9.21) | ||
| Race n (%) | ||||||||
| Other | 1 (2.3%) | 1 (1.4%) | 0.4248 | 1 (2.4%) | 1 (1.4%) | 0.4109 | ||
| White | 27 (100.0%) | 42 (97.7%) | 69 (98.6%) | 28 (100.0%) | 41 (97.6%) | 69 (98.6%) | ||
| Sex n (%) | ||||||||
| Female | 12 (44.4%) | 24 (55.8%) | 36 (51.4%) | 0.3542 | 13 (46.4%) | 23 (54.8%) | 36 (51.4%) | 0.4943 |
| Male | 15 (55.6%) | 19 (44.2%) | 34 (48.6%) | 15 (53.6%) | 19 (45.2%) | 34 (48.6%) | ||
| APOE4 status n (%) | ||||||||
| Heterozygous | 10 (37.0%) | 16 (37.2%) | 26 (37.1%) | 0.594 | 10 (35.7%) | 16 (38.1%) | 26 (37.1%) | 0.3664 |
| Homozygous | 2 (7.4%) | 3 (7.0%) | 5 (7.1%) | 2 (7.1%) | 3 (7.1%) | 5 (7.1%) | ||
| Carrier | 3 (7.0%) | 3 (4.3%) | 16 (57.1%) | 19 (45.2%) | 35 (50.0%) | |||
| Non-carrier | 15 (55.6%) | 20 (46.5%) | 35 (50.0%) | 4 (9.5%) | 4 (5.7%) | |||
| Unknown | 1 (2.3%) | 1 (1.4%) | ||||||
| PET SUVR status (cerebellum reference region; 1.12 cutoff) n (%) | ||||||||
| Negative | 9 (33.3%) | 11 (25.6%) | 20 (28.6%) | 0.4847 | 9 (32.1%) | 11 (26.2%) | 20 (28.6%) | 0.5892 |
| Positive | 18 (66.7%) | 32 (74.4%) | 50 (71.4%) | 19 (67.9%) | 31 (73.8%) | 50 (71.4%) | ||
| Cerebellum SUVR composite | ||||||||
| N | 18 | 32 | 50 | 0.5734 | 19 | 31 | 50 | 0.9642 |
| Mean (SD) | 1.4 (0.21) | 1.4 (0.15) | 1.4 (0.17) | 1.4 (0.22) | 1.4 (0.14) | 1.4 (0.17) | ||
| AD quality of life score—family report | ||||||||
| N | 27 | 43 | 70 | 0.4444 | 28 | 42 | 70 | 0.6817 |
| Mean (SD) | 36.8 (6.58) | 37.9 (5.45) | 37.5 (5.89) | 37.1 (6.68) | 37.7 (5.37) | 37.5 (5.89) | ||
| AD quality of life score—self report | ||||||||
| N | 27 | 43 | 70 | 0.3589 | 28 | 42 | 70 | 0.429 |
| Mean (SD) | 39.9 (5.91) | 41.0 (4.27) | 40.5 (4.95) | 40.0 (5.83) | 40.9 (4.31) | 40.5 (4.95) | ||
| ADAS-Cog 11 total score | ||||||||
| N | 26 | 43 | 69 | 0.0219 | 27 | 42 | 69 | 0.0309 |
| Mean (SD) | 22.1 (10.91) | 17.2 (6.23) | 19.1 (8.56) | 21.8 (10.78) | 17.3 (6.29) | 19.1 (8.56) | ||
| ADAS-Cog 14 total score | ||||||||
| N | 26 | 43 | 69 | 0.0102 | 27 | 42 | 69 | 0.0164 |
| Mean (SD) | 34.8 (13.03) | 27.9 (8.58) | 30.5 (10.92) | 34.4 (12.94) | 28.0 (8.67) | 30.5 (10.92) | ||
| ADCOMS | ||||||||
| N | 26 | 43 | 69 | 0.0079 | 27 | 42 | 69 | 0.0162 |
| Mean (SD) | 0.8 (0.34) | 0.6 (0.21) | 0.6 (0.28) | 0.7 (0.34) | 0.6 (0.21) | 0.6 (0.28) | ||
| Basic ADCS-ADL score | ||||||||
| N | 27 | 43 | 70 | 0.6483 | 28 | 42 | 70 | 0.7429 |
| Mean (SD) | 21.2 (1.28) | 21.4 (1.36) | 21.3 (1.32) | 21.3 (1.27) | 21.4 (1.38) | 21.3 (1.32) | ||
| Instrumental ADCS-ADL score | ||||||||
| N | 26 | 43 | 69 | 0.3394 | 27 | 42 | 69 | 0.4271 |
| Mean (SD) | 42.0 (9.91) | 44.2 (8.35) | 43.4 (8.96) | 42.3 (9.81) | 44.1 (8.42) | 43.4 (8.96) | ||
| Total ADCS-ADL score | ||||||||
| N | 26 | 37 | 63 | 0.1398 | 27 | 36 | 63 | 0.1876 |
| Mean (SD) | 63.3 (10.65) | 66.9 (8.54) | 65.4 (9.56) | 63.6 (10.55) | 66.8 (8.64) | 65.4 (9.56) | ||
| CDR global | ||||||||
| N | 27 | 43 | 70 | <0.0001 | 28 | 42 | 70 | 0.0003 |
| Mean (SD) | 1.1 (0.53) | 0.7 (0.25) | 0.9 (0.42) | 1.1 (0.53) | 0.7 (0.25) | 0.9 (0.42) | ||
| CDR sum of boxes | ||||||||
| N | 27 | 43 | 70 | 0.0018 | 28 | 42 | 70 | 0.0046 |
| Mean (SD) | 6.2 (2.79) | 4.6 (1.54) | 5.2 (2.25) | 6.1 (2.81) | 4.6 (1.54) | 5.2 (2.25) | ||
| MMSE-total score | ||||||||
| N | 27 | 43 | 70 | 0.0477 | 28 | 42 | 70 | 0.0817 |
| Mean (SD) | 19.7 (3.85) | 21.4 (3.28) | 20.8 (3.59) | 19.9 (3.87) | 21.4 (3.30) | 20.8 (3.59) | ||
| Mild/Moderate ADCOMS (MADCOMS) | ||||||||
| N | 26 | 43 | 69 | 0.3255 | 27 | 42 | 69 | 0.431 |
| Mean (SD) | 7.6 (2.63) | 7.0 (1.96) | 7.2 (2.23) | 7.5 (2.61) | 7.0 (1.97) | 7.2 (2.23) | ||
| NPI total score | ||||||||
| N | 26 | 36 | 62 | 0.2333 | 26 | 36 | 62 | 0.2333 |
| Mean (SD) | 3.4 (3.91) | 4.5 (3.36) | 4.0 (3.61) | 3.4 (3.91) | 4.5 (3.36) | 4.0 (3.61) | ||
| Whole brain volume in cm3 | ||||||||
| N | 20 | 36 | 56 | 0.2302 | 21 | 35 | 56 | 0.3179 |
| Mean (SD) | 1017.7 (122.80) | 1060.7 (129.35) | 1045.4 (127.63) | 1023.2 (122.27) | 1058.7 (130.64) | 1045.4 (127.63) | ||
| ZBI total score | ||||||||
| N | 27 | 43 | 70 | 0.7900 | 28 | 42 | 70 | 0.5678 |
| Mean (SD) | 21.9 (14.81) | 22.8 (13.28) | 22.5 (13.79) | 21.3 (14.88) | 23.3 (13.14) | 22.5 (13.79) | ||
As Treated and As Pre-Specified populations; PET, positron emission tomography; SUVR, standardized uptake value ratio; CDR-SB, clinical dementia rating-sum of boxes; NPI total score, Neuropsychiatric Inventory Score; ZBI total score, Zarit Burden Interview Score.