Genentech Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease
– Crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease –
– For more than a decade
– Initial data will be presented at the upcoming Alzheimer's
Small numerical differences favoring crenezumab were observed across the co-primary and multiple secondary and exploratory endpoints, but these were not statistically significant. No new safety issues were identified with crenezumab during the study. Further analyses of data are ongoing. Initial data will be presented at the Alzheimer's
“We’re disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said
The trial enrolled 252 people who are members of the world’s largest extended family with ADAD in
“While this is a disappointing result, we would like to thank the participants and their families - they have made an enormous contribution to advancing both understanding and the search for new treatments for familial Alzheimer's disease,” said
The study, which was supported by the
Within its Alzheimer’s pipeline,
About Banner Alzheimer’s Institute
Since its inception in 2006, Banner Alzheimer’s Institute (BAI) has sought to find effective Alzheimer’s disease prevention therapies without losing another generation, establish a new model of dementia care for patients and family caregivers, and forge new models of collaboration in biomedical research. It has made groundbreaking contributions to the unusually early detection, tracking, diagnosis and study of Alzheimer’s, and aims to find an effective prevention therapy by 2025. It includes the pioneering Alzheimer’s Prevention Initiative (API), an extensive profile of research studies and clinical trials, comprehensive clinical, family and community service programs, a leading brain imaging research program, and strategic partnerships with numerous public and private research organizations around the world.
About the Alzheimer’s Prevention Initiative and the API ADAD (
The Alzheimer’s Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer’s prevention research. Led by the Banner Alzheimer’s Institute, the API conducts prevention trials in cognitively healthy people at increased risk for Alzheimer’s disease. API continues to establish brain imaging, fluid biomarker and cognitive endpoints needed to rapidly test promising prevention therapies. It also leads participant recruitment registries to accelerate enrollment into Alzheimer’s-focused studies. API is intended to provide the scientific means, accelerated approval pathway and enrollment resources needed to evaluate the range of promising Alzheimer’s prevention therapies and find ones that work without losing another generation.
First proposed by investigators from BAI, the API ADAD trial (NCT01998841) was a prospective, randomized, double-blind, placebo-controlled, parallel-group label enabling Phase II study of the efficacy of crenezumab versus placebo in cognitively unimpaired individuals who have no clinical symptoms of Alzheimer’s disease and carry the PSEN1 E280A autosomal dominant mutation. Participants who are mutation carriers were randomized in a 1:1 ratio to receive either crenezumab or placebo for at least 260 weeks. Crenezumab was initially administered subcutaneously 300 mg every two weeks. Dosing was amended in 2015 to 720 mg subcutaneously every two weeks and in 2019 the option to increase the dose to 60 mg/kg, delivered intravenously every four weeks, was offered to participants. A cohort of participants (non-mutation carriers) were also enrolled and dosed solely on placebo.
The trial, which was supported by
For more information, go to https://alzheimerspreventioninitiative.com/.
About Autosomal Dominant Alzheimer’s Disease
Autosomal dominant Alzheimer’s Disease (ADAD; also known as familial AD or dominantly-inherited
About the PSEN1E280A mutation and the Antioquia kindreds
The PSEN1 E280A or ‘Paisa’ mutation virtually guarantees that carriers will develop Alzheimer’s at the average age of 44 and dementia at the average age of 49. The Colombian PSEN1 E280A kindred are the world’s largest extended family with ADAD, with ~6,000 family members and ~1,200 with the mutation.
The API ADAD trial was conducted in collaboration with neurologist
About crenezumab
Crenezumab is an investigational, monoclonal antibody designed to neutralize neurotoxic oligomers, a form of beta-amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimize 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). The investigational medicine was discovered by Swiss biotechnology company AC Immune SA.
About
Neuroscience is a major focus of research and development at
About
Founded more than 40 years ago,
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