Importance of the field: Alzheimer's disease is the leading cause of dementia in the elderly, and there is no disease-modifying therapy yet available. Immunotherapy directed against the β-amyloid peptide may be capable of slowing the rate of disease progression. Gantenerumab is the first fully human anti-β-amyloid monoclonal antibody.
Areas covered: To review the efficacy and safety of immunotherapy drugs and in particular gantenerumab, we used the database MEDLINE. The primary literature on gantenerumab is reviewed in its entirety. We also reviewed the English-language, pre-clinical and clinical trials designed to evaluate the efficacy or/and safety of immunotherapy drugs, from 1999 through 2011. Other Alzheimer's disease-passive immunotherapeutics currently in development, according to www.clinicaltrials.gov, are also discussed.
Expert opinion: Gantenerumab appears capable of reducing the cerebral β-amyloid peptide burden in patients with Alzheimer's disease. Its ability to slow disease progression remains uncertain because no clinical data are available at present. The next step will be to investigate whether removal of brain amyloid translates into clinical benefit for patients at doses of gantenerumab that reduce brain amyloid and are well tolerated.
Trial registration: ClinicalTrials.gov NCT01224106.