TABLE 1.
Baseline characteristics of participants of the Nolan Study (modified intention‐to‐treat population)
| Total | Nutritional blend | Placebo | ||
|---|---|---|---|---|
| n = 362 | n = 180 | n = 182 | ||
| mean (SD)* | mean (SD)* | mean (SD)* | P‐value | |
| Female sex | 212 (58.6%) | 104 (57.8%) | 108 (59.3%) | .763 d |
| Age (years) | 78.3 (4.8) | 78.4 (4.9) | 78.2 (4.8) | .724 e |
| Education (n = 361) | ||||
| <4 years | 4 (1.1%) | 2 (1.1%) | 2 (1.1%) | .836 f |
| 4 to 7 years | 28 (7.8%) | 16 (8.9%) | 12 (6.6%) | |
| 8 to 9 years | 61 (16.9%) | 28 (15.6%) | 33 (18.2%) | |
| ≥10 years | 268 (74.2%) | 134 (74.4%) | 134 (74.0%) | |
| Weight (kg) | 69.5 (13.1) | 69.5 (12.6) | 69.4 (13.6) | .917 g |
| Body mass index (kg/m2) | 26.1 (4.0) | 26.1 (4.1) | 26.2 (4.0) | .910 g |
| APOE ε4 status (n = 341) | ||||
| ε4 carrier | 83 (24.3%) | 38 (22.2%) | 45 (26.5%) | .361 d |
| ε4 non‐carrier | 258 (75.7%) | 133 (77.8%) | 125 (73.5%) | |
| Biomarkers | ||||
| Plasma homocysteine (µmol/L) (n = 356) | 12.3 (4.1) | 12.4 (4.5) | 12.2 (3.7) | .833 g,h |
| Erythrocyte ω‐3 index** (%) (n = 321) | 6.5 (1.3) | 6.5 (1.2) | 6.5 (1.3) | .726 g |
| 25 hydroxyvitamin D (ng/mL) (n = 356) | 26.2 (10.9) | 26.6 (11.6) | 25.9 (10.3) | .559 g |
| Cognitive tests | ||||
| CFI self‐assessment score (n = 342) | 4.4 (2.6) | 4.5 (2.6) | 4.4 (2.6) | .689 g |
| CFI study partner score (n = 330) | 3.4 (2.7) | 3.6 (2.7) | 3.2 (2.7) | .067 e |
| PROMIS T‐score (n = 337) | 50.8 (6.1) | 50.9 (6.1) | 50.7 (6.1) | .749 g |
| Composite cognitive score*** (n = 361) | 0.01 (0.70) | 0.00 (0.72) | 0.01 (0.69) | .936 g |
| MMSE score | 28.1 (1.6) | 28.1 (1.7) | 28.1 (1.6) | .964 e |
| CDR status | ||||
| Cognitively normal (CDR = 0) | 144 (39.8%) | 72 (40.0%) | 72 (39.6%) | .932 d |
| Mild cognitive impairment (CDR = 0.5) | 218 (60.2%) | 108 (60.0%) | 110 (60.4%) | |
| Brain imaging a | ||||
| Hippocampal volume (left) (mm3) (n = 280) b | 3477.7 (448.6) | 3465.4 (435.9) | 3490.4 (462.9) | .642 g |
| Hippocampal volume (right) (mm3) (n = 280) b | 3595.2 (466.2) | 3591.8 (439.0) | 3598.7 (494.2) | .903 g |
| Total hippocampal volume (mm3) (n = 280) b | 7072.9 (878.3) | 7057.2 (836.9) | 7089.0 (921.7) | .762 g |
| AD signature cortical thickness**** (mm) (n = 238) c | 2.8 (0.2) | 2.8 (0.2) | 2.8 (0.1) | .262 g |
Abbreviations: AD, Alzheimer's disease; CDR, Clinical Dementia Rating; CFI, Cognitive Function Instrument; MMSE, Mini‐Mental State Examination (score varies from 0 to 30); PROMIS, Patient‐Reported Outcomes Measurement Information System Applied Cognition‐Abilities.
Except where indicated otherwise. **ω‐3 index was calculated as the sum of % docosahexaenoic acid and % eicosapentaenoic acid, expressed as the percentage of total erythrocyte membrane fatty acids. ***Based on four cognitive tests (free and total recall of the Free and Cued Selective Reminding test, 10 Mini‐Mental State Examination orientation items, Digit Symbol Substitution Test, and Category Naming Test. ****Alzheimer's disease signature cortical thickness was composed of the mean cortical thickness of left and right hemispheres of four different regions of interest: entorhinal, inferior temporal, middle temporal, and fusiform weighted by each region's volume.
Imaging cohort was not different for baseline characteristics presented in this table compared to participants who did not perform MRI, except for age (77.9 vs. 80.0 years; P = .001).
n = 142 in the nutritional blend group and n = 138 in the placebo group.
n = 117 in the nutritional blend group and n = 121 in the placebo group.
Chi‐square test.
Kruskal‐Wallis test.
Fisher exact test.
Equal variance two sample t‐test.
P‐value with log transformation.