AC Immune Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease
Crenezumab did not statistically significantly slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease
Numerical differences favouring crenezumab over placebo were observed across the co-primary, multiple secondary and exploratory endpoints
Initial data will be presented at the Alzheimer's
Numerical differences favouring crenezumab over placebo were observed across the co-primary, multiple secondary and exploratory endpoints, though none were statistically significant. The co-primary endpoints assessed the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive total score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively. Crenezumab was generally well tolerated during the study and no new safety issues were identified. Further analyses of data are ongoing. Initial data will be presented at the Alzheimer's
“We are grateful to all those involved in this landmark study, which will undoubtedly increase the scientific community’s understanding of pre-symptomatic Alzheimer’s disease and prevention studies conducted in this population. We would like to especially recognize the trial participants and their families, whose courage continues to inspire us. We also thank our colleagues and partners at the Banner Alzheimer’s Institute (BAI), Grupo de Neurociencias de Antioquia (GNA), at the
The trial enrolled 252 people who are members of the world’s largest extended family with ADAD in
The study, which was supported by
Crenezumab is an investigational treatment discovered by
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, randomised, 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 randomised 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 PSEN1 E280A 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
Crenezumab is a humanised monoclonal antibody, an investigational treatment designed to slow Alzheimer’s disease progression by neutralising neurotoxic beta-amyloid oligomers. It was designed by
SupraAntigen® is a registered trademark of
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Forward looking statements
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Source: AC Immune SA