NCT01822951

Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Comparison of Cerebrolysin and Donepezil: A Randomized, Double-blind, Controlled Trial on Efficacy and Safety in Patients With Mild to Moderate Alzheimer's Disease

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ever Neuro Pharma GmbH · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Cerebrolysin	Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20. Placebo for donepezil:1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o.
DRUG	Donepezil	5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o. Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20.

Timeline

• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2013-04-04
• Last updated: 2015-10-26

Locations

1 site across 1 country: Austria