EXPEDITION3
Trial question
What is the effect of solanezumab in patients with mild dementia due to Alzheimer's disease and with amyloid deposition?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 2129
2129 patients (1231 female, 898 male).
Inclusion criteria: patients with mild dementia due to Alzheimer's disease and with amyloid deposition shown by means of florbetapir positron-emission tomography or Abeta1-42 measurements in CSF.
Key exclusion criteria: depression, serious or unstable medical conditions, recent infections, malignancies or psychiatric illnesses within the past 5 years, compromised renal function, clinically significant ECG abnormalities.
Interventions
N=1057 solanezumab (intravenous infusion at a dose of 400 mg every 4 weeks for 76 weeks).
N=1072 placebo (intravenous infusion every 4 weeks for 76 weeks).
Primary outcome
ADAS-cog14 score at 80 weeks
6.65 points
7.44 points
7.4 points
5.6 points
3.7 points
1.9 points
0.0 points
Solanezumab
Placebo
No significant
difference ↔
No significant difference in ADAS-cog14 score at 80 weeks (6.65 points vs. 7.44 points; AD -0.8 points, 95% CI -1.73 to 0.14).
Safety outcomes
No significant differences in adverse events (84.5% vs. 83.4%), adverse cerebral edema or effusion (1 vs. 2 patient), serious adverse events (16.6% vs. 18.9%), deaths (0.9% vs. 1.6%).
Conclusion
In patients with mild dementia due to Alzheimer's disease and with amyloid deposition shown by means of florbetapir positron-emission tomography or Abeta1-42 measurements in CSF, solanezumab was not superior to placebo with respect to a ADAS-cog14 score at 80 weeks.
Reference
Honig LS, Vellas B, Woodward M et al. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330.
Open reference URL