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Two Randomized Phas...
Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease
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- Budd Haeberlein, Samantha (författare)
- Biogen, Inc.
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- Aisen, P. S. (författare)
- University of Southern California
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- Barkhof, F. (författare)
- University College London
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visa fler...
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- Chalkias, S. (författare)
- Biogen, Inc.
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- Chen, T. (författare)
- Biogen, Inc.
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- Cohen, S. (författare)
- Toronto Memory Program
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- Dent, G. (författare)
- Biogen, Inc.
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- Hansson, O. (författare)
- Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Skåne University Hospital
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- Harrison, K. (författare)
- Biogen, Inc.
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- von Hehn, C. (författare)
- Biogen, Inc.
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- Iwatsubo, T. (författare)
- University of Tokyo
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- Mallinckrodt, C. (författare)
- Biogen, Inc.
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- Mummery, C. J. (författare)
- University College London
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- Muralidharan, K. K. (författare)
- Biogen, Inc.
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- Nestorov, I. (författare)
- Biogen, Inc.
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- Nisenbaum, L. (författare)
- Biogen, Inc.
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- Rajagovindan, R. (författare)
- Biogen, Inc.
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- Skordos, L. (författare)
- Biogen, Inc.
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- Tian, Y. (författare)
- Biogen, Inc.
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- van Dyck, C. H. (författare)
- Yale University School of Medicine
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- Vellas, B. (författare)
- Toulouse University Hospital
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- Wu, S. (författare)
- Biogen, Inc.
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- Zhu, Y. (författare)
- Biogen, Inc.
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- Sandrock, A. (författare)
- Biogen, Inc.
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Biogen, Inc University of Southern California (creator_code:org_t)
- 2022
- 2022
- Engelska 14 s.
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Ingår i: Journal of Prevention of Alzheimer's Disease. - : SERDI. - 2274-5807. ; 9:2, s. 197-210
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: Alzheimer’s disease is a progressive, irreversible, and fatal disease for which accumulation of amyloid beta is thought to play a key role in pathogenesis. Aducanumab is a human monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. Objectives: We evaluated the efficacy and safety of aducanumab in early Alzheimer’s disease. Design: EMERGE and ENGAGE were two randomized, double-blind, placebo-controlled, global, phase 3 studies of aducanumab in patients with early Alzheimer’s disease. Setting: These studies involved 348 sites in 20 countries. Participants: Participants included 1638 (EMERGE) and 1647 (ENGAGE) patients (aged 50–85 years, confirmed amyloid pathology) who met clinical criteria for mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, of which 1812 (55.2%) completed the study. Intervention: Participants were randomly assigned 1:1:1 to receive aducanumab low dose (3 or 6 mg/kg target dose), high dose (10 mg/kg target dose), or placebo via IV infusion once every 4 weeks over 76 weeks. Measurements: The primary outcome measure was change from baseline to week 78 on the Clinical Dementia Rating Sum of Boxes (CDR-SB), an integrated scale that assesses both function and cognition. Other measures included safety assessments; secondary and tertiary clinical outcomes that assessed cognition, function, and behavior; and biomarker endpoints. Results: EMERGE and ENGAGE were halted based on futility analysis of data pooled from the first approximately 50% of enrolled patients; subsequent efficacy analyses included data from a larger data set collected up to futility declaration and followed prespecified statistical analyses. The primary endpoint was met in EMERGE (difference of -0.39 for high-dose aducanumab vs placebo [95% CI, -0.69 to -0.09; P=.012; 22% decrease]) but not in ENGAGE (difference of 0.03, [95% CI, -0.26 to 0.33; P=.833; 2% increase]). Results of biomarker substudies confirmed target engagement and dose-dependent reduction in markers of Alzheimer's disease pathophysiology. The most common adverse event was amyloid-related imaging abnormalities-edema. Conclusions: Data from EMERGE demonstrated a statistically significant change across all four primary and secondary clinical endpoints. ENGAGE did not meet its primary or secondary endpoints. A dose-and time-dependent reduction in pathophysiological markers of Alzheimer’s disease was observed in both trials.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Nyckelord
- Aducanumab
- Alzheimer’s disease
- amyloid beta
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- art (ämneskategori)
- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Budd Haeberlein, ...
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Aisen, P. S.
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Barkhof, F.
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Chalkias, S.
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Chen, T.
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Cohen, S.
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visa fler...
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Dent, G.
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Hansson, O.
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Harrison, K.
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von Hehn, C.
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Iwatsubo, T.
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Mallinckrodt, C.
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Mummery, C. J.
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Muralidharan, K. ...
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Nestorov, I.
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Nisenbaum, L.
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Rajagovindan, R.
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Skordos, L.
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Tian, Y.
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van Dyck, C. H.
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Vellas, B.
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Wu, S.
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Zhu, Y.
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Sandrock, A.
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visa färre...
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