Effect of Immunotherapy With Bapineuzumab on Cerebrospinal Fluid Biomarker Levels in Patients With Mild to Moderate Alzheimer Disease
JAMA Neurology, 04/19/2012
Blennow K et al. – To the authors knowledge, this study is the first to show that passive Aβ immunotherapy with bapineuzumab results in decreases in cerebrospinal fluid (CSF) total tau (T–tau) and phosphorylated tau (P–tau), which may indicate downstream effects on the degenerative process. Cerebrospinal fluid biomarkers may be useful to monitor the effects of novel disease–modifying anti–Aβ drugs in clinical trials.Methods
- Forty-six patients with mild to moderate Alzheimer disease.
- Patients received either placebo (n=19) or bapineuzumab (n=27) in 3 or 4 ascending dose groups.
- Changes between end of study and baseline in the exploratory CSF biomarkers Aβ1-42, AβX-42, AβX-40; total tau (T-tau); and phosphorylated tau (P-tau).
- Within the bapineuzumab group, a decrease at end of study compared with baseline was found both for CSF T-tau (-72.3 pg/mL) and P-tau (-9.9 pg/mL).
- When comparing the treatment and placebo groups, this difference was statistically significant for P-tau (P=.03), while a similar trend for a decrease was found for T-tau (P=.09).
- No clear-cut differences were observed for CSF Aβ.