Table 3.
Cognition, function, and quality of life data for completers who remained on protocol for both treatment periods and achieved sustained physiological ketosis (12-week mean beta-hydroxybutyrate level ≥ 0.6 mmol/L) during the ketogenic diet intervention, showing mean baseline scores and changes at weeks 6 and 12 (data shown by treatment period, by treatment sequence, and for all patients)
| First treatment period | Second treatment period | All patients | Treatment effect | ||||
|---|---|---|---|---|---|---|---|
| Ketogenic-usual diet (n = 10) | Usual-ketogenic diet (n = 8) | Ketogenic-usual diet (n = 10) | Usual-ketogenic diet (n = 8) | Ketogenic diet (n = 18) | Usual diet (n = 18) | ||
| Cognition (ACE-III) | |||||||
| Baseline | 73.2 ± 14.3 | 68.3 ± 17.2 | 80.1 ± 14.4 | 66.0 ± 22.1 | 70.0 ± 18.0 | 74.8 ± 16.4 | + 2.56 ± 7.17 (P = 0.12) |
| Change at week 6 | + 4.90 ± 5.24 | 0.00 ± 4.41 | + 0.40 ± 4.03 | 0.00 ± 2.45 | + 2.72 ± 4.82 | + 0.22 ± 4.08 | |
| Change at week 12 | + 4.30 ± 4.55 | −3.00 ± 4.93 | − 0.10 ± 3.41 | − 2.75 ± 5.95 | + 1.17 ± 6.20 | −1.39 ± 4.29 | |
| Daily function (ADCS-ADL) | |||||||
| Baseline | 69.1 ± 6.5 | 64.6 ± 8.7 | 69.6 ± 8.7 | 60.3 ± 16.2 | 65.2 ± 12.3 | 67.4 ± 8.8 | + 2.95 ± 5.22 (P = 0.037) |
| Change at week 6 | + 1.10 ± 3.90 | − 1.00 ± 2.45 | − 0.70 ± 2.58 | + 0.63 ± 2.39 | + 0.89 ± 3.23 | −0.83 ± 2.46 | |
| Change at week 12 | + 0.70 ± 3.59 | −4.13 ± 5.46 | − 1.00 ± 2.79 | + 0.38± 3.66 | + 0.56 ± 3.52 | − 2.39 ± 4.35 | |
| Quality of life (QOL-AD) | |||||||
| Baseline | 35.4 ± 5.0 | 32.1 ± 5.8 | 36.9 ± 7.5 | 30.3 ± 8.2 | 33.1 ± 6.9 | 34.8 ± 7.1 | + 4.28 ± 7.27(P = 0.031) |
| Change at week 6 | + 0.10 ± 3.31 | + 1.00 ± 4.14 | − 0.90 ± 7.91 | + 1.75 ± 5.65 | + 0.83 ± 4.44 | −0.06 ± 6.41 | |
| Change at week 12 | + 3.50 ± 4.38 | − 0.63 ± 6.93 | − 0.70 ± 3.59 | + 3.75 ± 9.56 | + 3.61 ± 6.91 | − 0.67 ± 5.16 | |
Values are presented as mean ± standard deviation
Treatment effects and P values refer to the difference between the ketogenic and usual diet mean within-individual change at week 12 (for all patients)
ACE-III Addenbrookes Cognitive Examination – III, ADCS-ADL Alzheimer’s Disease Cooperative Study - Activities of Daily Living, QOL-AD Quality of Life in Alzheimer’s Disease