Alzheimer Disease Clinical Trial
Official title:
Comparison of Cerebrolysin and Donepezil: A Randomized, Double-blind, Controlled Trial on Efficacy and Safety in Patients With Mild to Moderate Alzheimer's Disease
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.
This phase IIIb/IV trial involves patients with mild to moderate Alzheimer's Disease in
Europe, Canada and Latin America and is designed as a prospective, randomized, double-blind,
active-controlled, parallel-group, multicenter, double-dummy trial.
The study endpoint is after 24 weeks. In total, five visits are scheduled in this trial and
a follow-up phone call is performed 4 weeks after Visit 5 (Week 24).
The first visit (Screening Visit, Visit 1) identifies participants who are eligible for and
interested in this trial.Efficacy and safety parameters are assessed at the Baseline Visit
(Visit 2), in Week 6-7 (Visit 3), Week 14-15 (Visit 4) and Week 24 (Visit 5).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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