. 2013 Jul 2;5:25. doi: 10.3389/fnagi.2013.00025

Table 1.

Clinical effects of anti-Aβ mAbs on CSF and plasma Aβ, adapted from Mavoungou and Schindowski (2013).

Study/cohort	Subcohort size for biomarker evaluation	Evaluated biomarker	Clinical effect of treatment on biomarker	Clinical effect on cognition	PK data of mAb	References
BAPINEUZUMAB (HUMANIZED 3D6)
201 Phase II	Placebo: n = 14	CSF Aß_x−42	No changes	In small cohort 6% less loss of ADAS-Cog scores after 18 months	Approximately 0.3%	Salloway et al., 2009
	BAPI: n = 20	Total CSF tau	No changes		Approximately 0.3%	Salloway et al., 2009
		CSF phospho-tau	Trend to reduction (p = 0.056)		CSF-plasma ratio
Phase II: pooled 201 and 202	Placebo: n = 19	CSFAß₁₋₄₀	No changes	Not determined	Not determined	Blennow et al., 2012
	BAPI: n = 26−27	CSF Aß_x−42	Decrease from baseline			Blennow et al., 2012
		CSF Aß₁₋₄₂	No changes
		Total CSF tau	No changes
		CSF phospho-tau	Reduction (p = 0.03)
Phase III: 301 (ApoE4 carrier)	Placebo: n = 77	CSF phospho-tau	No changes at 0.5 mg/kg	In a subcohort of mild cases at 1.0 mg/kg ~30% less loss of DAD scores after 18 months	Not determined	Salloway et al., 2012
	0.5mg/kg: n = 47	CSF phospho-tau	Reduction at 1.0 mg/kg			Salloway et al., 2012
	1.0mg/kg: n = 54
Phase III: 302 (ApoE4 non-carrier)	Placebo: n = 85	CSF phospho-tau	Reduction at 0.5 mg/kg	No effect on cognition after 18 months, even not for mild cases	Not determined	Sperling et al., 2012
Phase III: 302 (ApoE4 non-carrier)	0.5mg/kg: n = 127					Sperling et al., 2012
SOLANEZUMAB (HUMANIZED m266)
Phase II	Placebo: n = 8;	CSF total Aß₄₀	Increase at high dose	No significant cognitive benefit on the ADAS-cog score over after 12-weeks	0.1%	Farlow et al., 2012
	SOLA: n = 10−11 per dose group	CSF total Aß₄₂	Increase at high dose		CSF-plasma ratio
		CSF free Aß₄₀	Decrease at high dose
		CSF free Aß₄₂	Increase at high dose
		Plasma total Aß₄₀	Dose-dependent increase
		Plasma total Aß₄₂	Dose-dependent decrease
GSK933776 (DISCONTINUED FOR AD)
Phase I	Placebo: n = 14;	Plasma total Aß	Dose-dependent increase	Not determined	>0.2%	GlaxoSmithKline, 2011
	GSK933776: n = 3−6 per dose group	Plasma free Aß	Dose-dependent decrease		CSF-plasma ratio	GlaxoSmithKline, 2011
		CSF Aß₁₋₃₈ tau/phospho-tau	Increase at the highest dose
			No changes
CRENEZUMAB (MABT5 102A)
Phase I	MABT: n = 25−31 per regime group	Plasma total Aß₄₀	Dose-dependent increase	Not determined	Not determined	Adolfsson et al., 2012
	MABT: n = 25−31 per regime group	Plasma total Aß₄₀	Dose-dependent increase			Adolfsson et al., 2012