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. 2023 Sep 24;24(19):14499. doi: 10.3390/ijms241914499

Table 2.

Phase III trials testing solanezumab.

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.