Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared
to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In
addition, a traditional approach will be taken based on the evaluation of the separate risk
and benefit domains in comparison with donepezil.
Global risk-benefit as compared to donepezil will be analyzed by determining whether the
Cerebrolysin group shows a statistically significant non-inferiority with regard to the
combined primary safety and efficacy endpoints (weighted multivariate ensemble). The
endpoints will be combined by a global multivariate non-parametric procedure, weighting the
safety and efficacy part 50:50.