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Safety and biomarker effects of solanezumab in patients with Alzheimer’s disease


Farlow, Martin, Arnold, Steven E., van Dyck, Christopher H., Aisen, Paul S, Snider, B. Joy, Porsteinsson, Anton P., Friedrich, Stuart, Dean, Robert A., Gonzales, Celedon, Sethuraman, Gopalan, Demattos, Ronald B., Mohs, Richard, Paul, Steven M., Siemers, Eric R.


Alzheimer's & Dementia: The Journal Of The Alzheimer's Association, Volume: 8, No.: 4, Pages.: 261-271

Year of Publication



Objectives: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of 12 weekly infusions of solanezumab, an anti-β-amyloid (Aβ) antibody, in patients with mild-to-moderate Alzheimer’s disease. Cognitive measures were also obtained.; Methods: In this phase 2, randomized, double-blind, placebo-controlled clinical trial, 52 patients with Alzheimer’s disease received placebo or antibody (100 mg every 4 weeks, 100 mg weekly, 400 mg every 4 weeks, or 400 mg weekly) for 12 weeks. Safety and biomarker evaluations continued until 1 year after randomization. Both magnetic resonance imaging and cerebrospinal fluid (CSF) examinations were conducted at baseline and after the active treatment period. The Aβ concentrations were measured in plasma and CSF, and the Alzheimer’s Disease Assessment Scale-cognitive portion was administered.; Results: Clinical laboratory values, CSF cell counts, and magnetic resonance imaging scans were unchanged by treatment, and no adverse events could be clearly related to antibody administration. Total (bound to antibody and unbound) Aβ(1-40) and Aβ(1-42) in plasma increased in a dose-dependent manner. Antibody treatment similarly increased total Aβ(1-40) and Aβ(1-42) in CSF. For patients taking 400 mg weekly, antibody treatment decreased unbound Aβ(1-40) in CSF (P < .01), but increased unbound Aβ(1-42) in CSF in a dose-dependent manner. The Alzheimer's Disease Assessment Scale-cognitive portion was unchanged after the 12-week antibody administration.; Conclusions: Antibody administration was well tolerated with doses up to 400 mg weekly. The dose-dependent increase in unbound CSF Aβ(1-42) suggests that this antibody may shift Aβ equilibria sufficiently to mobilize Aβ(1-42) from amyloid plaques.; Copyright © 2012 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Bibtex Citation

@article{Farlow_2012, doi = {10.1016/j.jalz.2011.09.224}, url = {}, year = 2012, month = {jul}, publisher = {Elsevier {BV}}, volume = {8}, number = {4}, pages = {261--271}, author = {Martin Farlow and Steven E. Arnold and Christopher H. van Dyck and Paul S. Aisen and B. Joy Snider and Anton P. Porsteinsson and Stuart Friedrich and Robert A. Dean and Celedon Gonzales and Gopalan Sethuraman and Ronald B. DeMattos and Richard Mohs and Steven M. Paul and Eric R. Siemers}, title = {Safety and biomarker effects of solanezumab in patients with~Alzheimer's disease}, journal = {Alzheimer{textquotesingle}s {&} Dementia} }


a, adverse, aged, aged, 80 and over, alzheimer disease, amyloid betapeptides, antiamyloid, antibodies monoclonal humanized, antibody, cerebrospinal fluid, cognition disorders, complications, diagnostic use, doseresponse relationship drug, doubleblind method, drug therapy, electroencephalography, enzymelinked immunosorbent assay, etiology, events, female, followup studies, humans, male, middle aged, neuropsychological tests, peptide fragments, psychiatric status rating scales, pyridines, radionuclide imaging, solanezumab, therapeutic use, tomography emissioncomputed singlephoton, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions