Asset profile
Cerebrolysin
Peptide
Evidence outlook · lead readout
NCT00911807 · Alzheimer Disease
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.
NCT00911807: This was a randomized, quadruple-blinded, three-arm trial with 217 patients, comparing Cerebrolysin plus donepezil, Cerebrolysin alone, and donepezil alone. The primary endpoint, change in ADAS-Cog+ at week 28, did not show a statistically significant difference among the groups (overall p=0.6348; pairwise comparisons all non-significant), so the study did not meet its primary cognitive endpoint. Although the design was strong, the null primary result limits the evidence to a moderate level.
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