Table 2.
Study Design and Duration |
Study Population |
Cognitive Primary Endpoint | CSF or Plasma Aβ | Amyloid PET |
Volumetric MRI |
---|---|---|---|---|---|
Phase III, randomised, double-blind, placebo-controlled (EXPEDITION 1, 2) 80 weeks [54] |
Mild to moderate AD |
ADAS-Cog11 and ADCS-ADL Significant small effects for ADCS-ADL only in EXPEDITION 2 Significant small effects in a secondary analysis on the pooled mild AD-population [55] |
Significant increase in plasma and CSF |
No significant effects |
No significant effects |
Phase III, randomised, double-blind, placebo-controlled (EXPEDITION 3) 76 weeks [56] |
Mild AD | ADAS-Cog11 No significant effects |
Significant increase in plasma and CSF |
No significant effects |
No significant effects |
Phase III, randomised, double-blind, placebo-controlled (A4) 240 weeks [58] |
Preclinical AD | PACC No significant effects |
ND | Smaller increase vs. placebo | No significant effects |
Phase II/III, randomised, double-blind, placebo-controlled (DIAN-TU) 208 weeks [72] |
Dominantly inherited AD |
DIAN-MCE No significant effects |
Significant increase in CSF | No significant effects | No significant effects |
ND, not determined.