From: Alzheimer's disease therapeutic research: the path forward
 | Mild AD Trial | Early AD Trial | Very early AD Trial |
---|---|---|---|
Cognitive status | Mild dementia | Mild cognitive impairment | Cognitively normal |
CDR global score | 0.5 to 1 | 0.5 | 0 |
MMSE range | 16 to 26 | 25 to 30 | 28 to 30 |
Biomarker for subject selection | None | Amyloid imaging and/or CSF Aβ42 | Amyloid imaging and/or CSF Aβ42 |
Biomarker for subject stratification | None or APOE genotype | APOE genotype | APOE genotype |
Primary cognitive outcome measure | ADAS-cog11 | ADAS-cog12 (includes delayed recall) | Sensitive memory and/or executive function measure |
Primary global/functional outcome measure | CDR-SB | CDR-SB | None |
Analysis covariates | Baseline cognition and regional brain volume | Baseline cognition and regional brain volume | Regional brain volume |
Biomarker outcome | Regional brain atrophy | Regional brain atrophy | Regional brain atrophy and/or amyloid measure (as surrogate endpoint) |
Duration of treatment | 18 months | 24 months | 24 to 36 months |
Primary analysis | Change score or slope of co-primaries: ADAS-cog11, CDR-SB | Change score or slope of co-primaries: ADAS-cog12, CDR-SB | Regional brain atrophy rate and cognitive decline |