Table 2.
Baseline characteristics intention-to-treat population
| N | Placebo group, n = 25 | Intervention group, n = 25 | |
|---|---|---|---|
| Age (years) | 50 | 66 ± 8 | 65 ± 7 |
| Female | 50 | 11 (44) | 12 (48) |
| Education | 50 | 6 (4–7) | 5 (4–7) |
| Positive family history∗ | 50 | 7 (28) | 6 (24) |
| Apolipoprotein E ε4 carrier | 46 (25:21) | 21 (84) | 16 (76) |
| Body weight (kg) | 50 | 75 ± 13 | 73 ± 17 |
| BMI (kg/m2) | 45 (23:22) | 24 ± 3 | 25 ± 4 |
| Systolic blood pressure (mmHg) | 49 (24:25) | 147 ± 18 | 151 ± 23 |
| Diastolic blood pressure (mmHg) | 49 (24:25) | 86 ± 9 | 88 ± 11 |
| Pulse (/min) | 49 (24:25) | 61 ± 11 | 66 ± 7 |
| Fasting glucose before PET | 50 | 5.2 ± 0.52 | 5.4 ± 0.72 |
| MMSE† | 50 | 25 ± 3 | 25 ± 3 |
| RAVLT immediate recall (sum of 5 trials) | 50 | 28 (8–39) | 29 (14–41) |
| RAVLT delayed recall | 49 (24:25) | 2 (0–6) | 2 (0–10) |
| TMT version A (sec) | 50 | 48 (18–140) | 46 (27–225) |
| TMT version B (sec) | 42 (21:21) | 85 (47–299) | 136 (56–334) |
| MTA (mean of left and right)† | 50 | 1.5 (0–3) | 1.0 (0–3) |
| WMH† | 50 | 1 (0–2) | 1 (0–2) |
| CSF tau/amyloid-β 1–42† | 44 (22:22) | 1.35 ± 0.83 | 1.27 ± 0.46 |
| Abnormal amyloid PET scan | 20 (13:7) | 13 (100) | 7 (100) |
NOTE. Data are presented in mean ± standard deviation, median (minimum-maximum), or n (%). Education is calculated according to the Verhage scale (1–7, respectively, low-high education [19]). Using ANOVA, Kruskal-Wallis, or χ2 analyses when appropriate, no statistically significant differences between groups were found.
Abbreviations: AD, Alzheimer's disease; CSF, cerebrospinal fluid; MMSE, Mini–Mental State Examination; PET, positron emission tomography; MRI, magnetic resonance imaging; RAVLT, Rey Auditory Learning Verbal Learning Test; TMT, Trail Making Test time to complete; MTA, medial temporal lobe atrophy visual rating scale (0–4) in which higher scores reflect more severe atrophy [20]; WMH, white matter hyperintensities based on the Fazekas rating scale (0–3) in which higher scores reflex more white matter lesions [21]; CSF tau/amyloid-β 1–42, cerebrospinal fluid total tau/amyloid β 1–42, in which a value > 0.52 has found to be associated with AD [14].
Positive family history = first-degree family member with AD before age 66 years.
Screening variables: MMSE at screening visit, MRI within one year before inclusion, CSF, or amyloid PET at any time before baseline.