drugset / Trial / NCT00911807

Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease

NCT00911807

Phase 2 Completed 217 enrolled Ever Neuro Pharma GmbH acromion GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters \[ml\]), Aricept (10 miligrams \[mg\]), and a combination of both treatments on cognitive performance and global function in patients with probable Alzheimer's Disease (AD). It should also be assessed if the treatments have a positive effect on activities of daily living and neuropsychiatric symptoms. Oral treatment with Aricept or Placebo was given once daily throughout the study. Intravenous treatment with Cerebrolysin or Placebo was given once daily for 5 days per week during week 1 to 4 and during week 13 to 16 of the study. During the study patients had six visits at the hospital for evaluation.

Timeline

Start
2004-10
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cerebrolysin Peptide 10 ml Intravenous
Subject Donepezil Small molecule 10 mg Oral

Indications