Egan 2018

Study ID(s) and Acronym(s)
NCT01739348
Current Status of Trial
Terminated/Stopped Early
Study Aim
Treatment Dementia
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Verubecestat // Placebo
Dosage and Duration
A total of 1958 patients underwent randomization; 653 were randomly assigned to receive verubecestat at a dose of 12 mg per day (the 12-mg group), 652 to receive verubecestat at a dose of 40 mg per day (the 40-mg group), and 653 to receive matching placebo.
Absolute Number of Participants
1958
Health Status/Diagnosis
Alzheimer Disease (AD)
Co-morbid Health Condition/Other Participant Characteristics
Mild to moderate AD
Primary outcomes
Cognition (ADAS-cog) // Activities of Daily Living ( Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale)
Key Points
"The trial was terminated early for futility 50 months after onset, which was within 5 months before its scheduled completion, and after enrollment of the planned 1958 patients was complete. The estimated mean change from baseline to week 78 in the ADAS-cog score was 7.9 in the 12-mg group, 8.0 in the 40-mg group, and 7.7 in the placebo group (P=0.63 for the comparison between the 12-mg group and the placebo group and P=0.46 for the comparison between the 40-mg group and the placebo group). The estimated mean change from baseline to week 78 in the ADCS-ADL score was -8.4 in the 12-mg group, -8.2 in the 40-mg group, and -8.9 in the placebo group (P=0.49 for the comparison between the 12-mg group and the placebo group and P=0.32 for the comparison between the 40-mg group and the placebo group). Adverse events, including rash, falls and injuries, sleep disturbance, suicidal ideation, weight loss, and hair-color change, were more common in the verubecestat groups than in the placebo group." Egan 2018