Asset profile
AstroStem
Cell therapy
Evidence outlook · lead readout
NCT03117738 · Alzheimer Disease
The reported results come from study designs that frequently fail to replicate under controlled conditions — see the rationale below.
NCT03117738: This trial was randomized and triple-blinded with a placebo control, which is a strong design foundation, but it enrolled only 21 participants (11 vs 10, with substantial dropout leaving just 7 per arm for the cognitive endpoint), making it severely underpowered. The primary cognitive endpoint (ADAS-Cog change) numerically favored placebo over AstroStem, and no p-value or confidence interval was reported for either primary outcome, so the primary comparison cannot be called a success for the drug.
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