NCT03978338 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H
A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease. Eur J Neurol. 2006 Jan;13(1):43-54.
Alvarez XA, Cacabelos R, Sampedro C, Couceiro V, Aleixandre M, Vargas M, Linares C, Granizo E, García-Fantini M, Baurecht W, Doppler E, Moessler H
Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil. Curr Alzheimer Res. 2011 Aug;8(5):583-91.
Gauthier S, Proaño JV, Jia J, Froelich L, Vester JC, Doppler E
Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials. Dement Geriatr Cogn Disord. 2015;39(5-6):332-47. doi: 10.1159/000377672. Epub 2015 Mar 26.
Kmietowicz Z
Mediterranean diet is associated with reduced brain shrinkage in older people, study finds. BMJ. 2015 Oct 21;351:h5556. doi: 10.1136/bmj.h5556.
McEvoy CT, Guyer H, Langa KM, Yaffe K
Neuroprotective Diets Are Associated with Better Cognitive Function: The Health and Retirement Study. J Am Geriatr Soc. 2017 Aug;65(8):1857-1862. doi: 10.1111/jgs.14922. Epub 2017 Apr 25.
Muresanu DF, Alvarez XA, Moessler H, Buia M, Stan A, Pintea D, Moldovan F, Popescu BO
A pilot study to evaluate the effects of Cerebrolysin on cognition and qEEG in vascular dementia: cognitive improvement correlates with qEEG acceleration. J Neurol Sci. 2008 Apr 15;267(1-2):112-9. Epub 2007 Nov 28.

A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Improving Cognitive Function in Mild Alzheimer's Disease

Details for clinical trial NCT03978338

Clinical trial NCT03978338 - References