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The Alzheimer's Prevention Initiative Autosomal‐Dominant Alzheimer's Disease Trial: A study of crenezumab versus placebo in preclinical PSEN1 E280A mutation carriers to evaluate efficacy and safety in the treatment of autosomal‐dominant Alzheimer's disease, including a placebo‐treated noncarrier cohort
Open accessAbstract
Introduction: Autosomal‐dominant Alzheimer's disease (ADAD) represents a crucial population for identifying prevention strategies that might modify disease course for cognitively unimpaired individuals at high imminent risk for developing symptoms due to Alzheimer's disease (AD), that is, who have “preclinical” AD. Crenezumab is an antiamyloid monoclonal antibody that binds monomeric and aggregated forms of amyloid β, with highest affinity for oligomers; it is in development for early stages of sporadic AD and for ADAD. Methods: This is a prospective, randomized, double‐blind, placebo‐controlled phase 2 study of the efficacy of crenezumab versus placebo in asymptomatic PSEN1 E280A mutation carriers from family kindreds with ADAD in Colombia. Participants were randomized to receive either crenezumab or placebo for 260 weeks. The study was designed to enroll a planned total of 300 participants, including 200 preclinical mutation carriers (approximately 100 treatment, 100 placebo) and an additional control group of mutation noncarriers from the same family kindreds included to mask mutation carrier status (100 placebo only). The primary outcome is change in the Alzheimer's Prevention Initiative ADAD Composite Cognitive Test Score from baseline to week 260. Secondary outcomes include time to progression to mild cognitive impairment due to AD or dementia due to AD; changes in dementia severity, memory, and overall neurocognitive functioning; and changes in amyloid–positron emission tomography, fluorodeoxyglucose–positron emission tomography, magnetic resonance imaging volumes, and cerebrospinal fluid levels of β amyloid, tau, and p‐tau. Safety and tolerability are assessed. Results: Two hundred fifty‐two participants were enrolled between December 2013 and February 2017. Discussion: We describe the first large‐scale, potentially label‐enabling clinical trial of a preclinical treatment for ADAD. Results from this trial will inform on the efficacy of crenezumab for delaying onset of, slowing decline in, or preventing cognitive impairment in individuals with preclinical ADAD and will foster an improved understanding of AD biomarkers and their relationship to clinical outcomes.
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“Crenezumab is being used in the API ADAD Colombia trial of known mutation carriers (Tariot et al., 2018), whereas active immunization with CAD106 is being used in the API Generation trial of APOE ε4 homozygotes (Lopez Lopez et al., 2019).”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Tariot et al., 2018
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Metadata
- Authors
- Tariot, P. N., Lopera, F., Langbaum, J. B., Thomas, R. G., Hendrix, S., Schneider, L. S., Rios‐Romenets, S., Giraldo, M., Acosta, N., Tobon, C., Ramos, C., Espinosa, A., Cho, W., Ward, M., Clayton, D., Friesenhahn, M., Mackey, H., Honigberg, L., Sanabria Bohorquez, S., Chen, K., Walsh, T., Langlois, C., Reiman, E. M., & Initiative, A. P.
- Affiliations
- Banner Alzheimer’s Institute (US)
- Universidad de Antioquia (CO)
- University of California San Diego (US)
- Pentara Corporation Salt Lake City UT USA
- University of Southern California (US)
- Grupo de Neurociencias Universidad de Antioquia, SIU Medellín Colombia
- Genentech, a Member of the Roche Group South San Francisco CA USA
- Genentech (US)
- Corresponding author
- Tariot, Pierre N.
- ORCID
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2018-01
- Volume
- 4
- Issue
- 1
- Pages
- 150-160
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC6021543
- OpenAlex
- W2789516300
- Cited by
- 128
- References
- 65
- Citations by year
- 2026: 1 · 2025: 9 · 2024: 9 · 2023: 13 · 2022: 13 · 2021: 19 · 2020: 32 · 2019: 20 · 2018: 7
- FWCI
- 13.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Repositorio Digital - Academia Colombiana de Ciencias Exactas, Fisicas y Naturales (submittedVersion, other-oa)
- Funders
- National Institute on Aging (1RFAG041705‐01A1)
- NOMIS Stiftung
- Flinn Foundation (1862)
- AstraZeneca
- H. Lundbeck A/S
- Merck
- Roche
- Amgen
- Biogen
- Elan
- GE Healthcare
- Genentech
- Novartis
- Arizona Department of Health Services
- Foundation for Biomedical Research and Innovation
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Clinical Neurology › Amyotrophic Lateral Sclerosis Research
- Keywords
- autosomal dominant Alzheimer's disease, crenezumab, preclinical Alzheimer's disease, PSEN1 E280A mutation, amyloid-beta oligomers, anti-amyloid monoclonal antibodies, cognitive decline prevention, amyloid PET, cerebrospinal fluid biomarkers, tau protein, familial kindred, treatment efficacy and safety
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