TABLE 2.
Double‐blind placebo‐controlled Phase 1 Visits 0–4 | Double‐blind placebo‐ controlled Phase 2 (crossover) Visits 5–8 | Open label MCT extension Phase 3 Visits 9–12 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Variable | Placebo start | MCT start | P | Placebo start | MCT start | P | Placebo start | MCT start | P | P model for group effects |
MMSE | 23.8 ± 4.7 | 22.8 ± 6.4 | .75 | 23.7± 4.8 | 21±6.9 | .44 | 23.4±5.5 | 20.1±7.7 | .06 | .05 |
MoCA | 18.6± 6.5 | 25.4±7.2 | .04 | 19.7±5.4 | 14.8±7.9 | .12 | 17.1±5.1 | 16±7.3 | .5 | .08 |
Cog 1 | 90.2±15.9 | 76.7±21.6 | .12 | 91.3±13.7 | 79.2 ± 22.9 | .17 | 89.8±19.3 | 80.5±21.2 | .09 | .003* |
Cog 2 | 84.9±13.1 | 80.8±24.3 | .62 | 84.4±12.9 | 73.1±27.7 | .24 | 88.7 ± 13.5 | 83.8±21.9 | .3 | .02 |
Cognitive scores in each phase of the study. (Placebo start refers to group starting study in placebo arm, MCT start refers to group starting in MCT arm).
Abbreviations: MCT, medium chain triglyceride; MMSE, Mini Mental Status Examination; MoCA, Montreal Cognitive Assessment; Cog 1, Cognigram® Part 1; Cog 2, Cognigram® Part 2.
*Statistically significant result.