Crenezumab continues to be studied in the Alzheimer’s Prevention Initiative (API) trial investigating a different study population from that of the CREAD programme, namely cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk to develop familial AD (ADAD). The five-year study is in collaboration with the Banner Institute and is funded by the National Institute on Aging.
About the molecules and development programmes
Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of neurotoxic oligomers, a form of beta-amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimise the inflammatory response in the brain, which may result in a lower risk of certain MRI (magnetic resonance imaging) abnormalities known as ARIA (Amyloid-Related Imaging Abnormalities). Crenezumab is being developed by Roche and was discovered by Swiss biotechnology company AC Immune SA.
Gantenerumab is an investigational, IgG1 monoclonal antibody, which has a distinct mechanism of action from crenezumab. It is designed to bind to aggregated forms of beta-amyloid and has previously demonstrated amyloid plaque lowering in AD patients. The clinical significance of this effect is being investigated in two Phase III studies (GRADUATE 1 and 2), which are assessing the safety and efficacy of subcutaneous gantenerumab for the treatment of early AD patients. The GRADUATE programme is currently enrolling more than 1,500 patients in up to 350 study centres in more than 30 countries worldwide. Gantenerumab is the only late stage anti-amyloid programme being developed with subcutaneous administration, which may, if approved, enable home administration for the patients and caregivers affected by this disease. Data readout is expected in 2022. Gantenerumab is also being studied in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) trial, a global clinical study evaluating multiple compounds in individuals at risk for or with fAD.
RG6100 (anti-tau) is an investigational, monoclonal IgG4 antibody that binds to multiple tau species. This antibody is also part of a collaboration with AC Immune SA. It is proposed to slow the prion-like propagation of tau pathology in AD. Tau pathology spreads with a characteristic spatiotemporal pattern throughout the brain, coinciding with both clinical symptoms and disease progression in AD. Slowing the propagation of tau pathology may therefore slow disease progression and reduce cognitive decline. Anti-tau therapies have shown promise in slowing the progression of tau pathology in animal models of tauopathy. RG6100 is currently in Phase II clinical evaluation for its potential to slow or stop the progression of AD.
About Alzheimer’s disease
Alzheimer’s disease (AD) is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving, and impairs daily functioning such as the ability to manage one’s own activities. Biological changes in the brain are believed to start decades before clinical symptoms of AD become evident. In the early stages (prodromal to mild), people may have difficulty remembering; their daily function may or may not be impaired but independence is maintained. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 50 million people worldwide with 10 million new cases each year, of which AD is the most common form. There is no cure for AD. Current treatments focus on alleviating symptoms but are unable to stop the progression of AD because they do not affect the disease’s underlying causes.
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