TABLE 1.
Comparison of Enrollers and Nonenrollers in the Magnetic Resonance Imaging Substudy at Baseline: Demographic, Medical, and Clinical Outcome Characteristics in the Docosahexanoic Acid Trial
| AD Clinical Trial 1* |
AD Clinical Trial 2 |
|||||
|---|---|---|---|---|---|---|
| Enrollers (N = 166) | Nonenrollers (N = 236) | P† | Enrollers (N = 161) | Nonenrollers (N = 152) | P† | |
| Demographics | ||||||
| Age (years) | 75.4 ± 8.9 | 76.7 ± 8.5 | 0.16 | 74.9 ± 8.3 | 76.7 ± 7.3 | 0.035 |
| Women, no (%) | 81 (49) | 129 (55) | 0.29 | 97 (60) | 87 (57) | 0.67 |
| Education (years) | 14.1 ± 2.6 | 14.4 ± 2.9 | 0.39 | 13.8 ± 3.2 | 13.8 ± 3.4 | 0.92 |
| White race, No (%) | 151 (91) | 217 (92) | 0.87 | 148 (92) | 141 (93) | 0.95 |
| AD onset (years since) | 4.4 ± 2.5 | 4.0 ± 2.4 | 0.11 | 6.8 ± 2.6 | 6.9 ± 2.6 | 0.66 |
| Alcohol abuse, no (%) | 7 (4) | 4 (2) | 0.21 | 9 (6) | 3 (2) | 0.14 |
| Smoking, no (%) | 38 (23) | 56 (24) | 0.94 | 47 (29) | 39 (26) | 0.57 |
| Weight (kg) | 73.6 ± 14.2 | 71.7 ± 14.2 | 0.19 | 70.9 ± 14.3 | 71.4 ± 13.4 | 0.74 |
| Height (cms) | 167.7 ± 9.7 | 165.1 ± 10.7 | 0.01 | 164.6 ± 10.6 | 165.6 ± 10.6 | 0.38 |
| Diastolic BP | 72.9 ± 10.3 | 72.9 ± 9.8 | 0.99 | 73.2 ± 9.8 | 76.9 ± 9.1 | <0.001 |
| Systolic BP | 133.4 ± 18.6 | 132.3 ± 17.8 | 0.58 | 136.7 ± 18.4 | 136.6 ± 16.7 | 0.99 |
| Total DHA levels | 90.0 ± 56.2 | 88.3 ± 51.0 | 0.75 | — | — | |
| Total EPA levels | 55.1 ± 40.9 | 53.0 ± 34.2 | 0.59 | — | — | |
| Cognitive, Behavioral | ||||||
| MMSE | 20.15 ± 3.6 | 21.04 ± 3.6 | 0.02 | 17.03 ± 2.9 | 16.8 ± 2.9 | 0.48 |
| CDR-SOB | 5.74 ± 2.7 | 5.62 ± 2.6 | 0.65 | 7.14 ± 2.9 | 7.48 ± 2.9 | 0.30 |
| CDR (treated as continuous) | 0.95 ± 0.5 | 0.97 ± 0.5 | 0.61 | 1.17 ± 0.6 | 1.27 ± 0.5 | 0.12 |
| CDR | 0.56 | 0.071 | ||||
| 0.5 | 60 (36) | 78 (33) | 26 (16) | 18 (12) | ||
| 1 | 85 (51) | 127 (54) | 97 (60) | 84 (55) | ||
| 2 | 21 (13) | 30 (13) | 35 (22) | 50 (33) | ||
| 3 | 0 (0) | 1(0) | 3 (2) | 0 (0) | ||
| Modified Hachinski | 0.62 ± 0.72 | 0.88 ± 0.81 | <0.0001 | — | — | |
| NPI | 9.48 ± 10.9 | 8.69 ± 10.3 | 0.47 | 2.52 ± 2.7 | 3.20 ± 2.6 | 0.022 |
| QOL subject rating | 40.64 ± 4.8 | 39.81 ± 5.2 | 0.11 | 40.28 ± 6.0 | 39.77 ± 5.1 | 0.42 |
| QOL partner rating | 36.62 ± 6.1 | 36.68 ± 5.8 | 0.92 | 36.97 ± 6.2 | 37.57 ± 5.6 | 0.37 |
| ADCS-ADL | 59.17 ± 12.8 | 60.50 ± 12.4 | 0.30 | 54.35 ± 13.5 | 52.41 ± 13.3 | 0.20 |
| ADASCog11 | 24.99 ± 8.5 | 23.03 ± 9.3 | 0.03 | 29.27 ± 8.8 | 30.50 ± 10.0 | 0.25 |
Bold values indicates P<0.05.
Data were expressed as means±SD for continuous variables and number (%) for categorical variables
Two individuals had unreadable scans, one owing to poor quality of motion and the other owing to the participant noncompliance and were not considered enrollers.
From χ2 (proportions) or t test (means); ordinal CDR compared using ordinal logistic regression.
AD indicates Alzheimer disease; ADASCog11, Alzheimer’s Disease Cooperative Study 11 item Cognitive scale; ADCS-ADL, Alzheimer’s Disease Cooperative Study-Activities of Daily Living; BP, blood pressure; CDR, Clinical Dementia Rating; CDR-SOB, Clinical Dementia Rating Scale-Sum of Boxes; DHA, docosahexanoic acid; EPA, eicosapentaenoic acid; MMSE, Mini Mental State Exam; NPI, Neuropsychiatric Inventory; QOL, quality of life.