Emerge and Engage topline results: Phase 3 studies of aducanumab in early Alzheimer’s disease: Developments in clinical trials and cognitive assessment
Open accessAbstract
Abstract Background Aducanumab is a human monoclonal antibody that selectively targets aggregated forms of Aβ, including soluble oligomers and insoluble fibrils. EMERGE and ENGAGE are two 18‐month, randomized, double‐blind, placebo‐controlled, global Phase 3 studies with identical design that evaluated the efficacy and safety of aducanumab in patients aged 50–85 years with early Alzheimer’s disease (MCI due to AD or mild AD dementia). Method Key inclusion criteria included positive amyloid PET, MMSE score of 24–30, CDR Global score of 0.5, and an RBANS‐DMI score ≤85. During the 18‐month placebo‐controlled period, patients were randomized 1:1:1 to low‐dose aducanumab, high‐dose aducanumab, or placebo, administered via IV infusion every 4 weeks. The primary endpoint for EMERGE and ENGAGE was change from baseline at Week 78 on the CDR‐SB. Secondary endpoints included change from baseline on MMSE, ADAS‐Cog13, and ADCS‐ADL‐MCI. Result Following pre‐planned futility analysis, analysis of the data from the final database lock showed that EMERGE met its primary endpoint, based on the pre‐specified statistical analysis plan. Patients treated with high dose aducanumab showed a significant reduction of clinical decline from baseline in CDR‐SB scores at 78 weeks (22% versus placebo, P = 0.01). ENGAGE did not meet its primary endpoint. However, data from patients in ENGAGE who achieved sufficient exposure to high dose aducanumab supported the findings of EMERGE. Conclusion EMERGE met its primary endpoint, based on the pre‐specified statistical analysis plan. Data from a subset of patients in ENGAGE support the results of EMERGE. The safety and tolerability profile of aducanumab in EMERGE and ENGAGE was consistent with previous studies of aducanumab.
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The approval of the first mAb against AD was given without a definitively proven clinical benefit based on its effects on AD biomarkers.
“The approval of the first mAb against AD was given without a definitively proven clinical benefit based on its effects on AD biomarkers [47,62,64,65].”
From Treatment of Alzheimer’s Disease: Beyond Symptomatic Therapies (2023) · cites this paper as [64]
Aducanumab received accelerated approval by the FDA for the treatment of mild cognitive impairment due to AD and mild AD dementia on 7 June 2021.
“This led to the accelerated approval of Aducanumab by the FDA for the treatment of mild cognitive impairment due to AD and mild AD dementia on 7 June 2021.”
From Treatment of Alzheimer’s Disease: Beyond Symptomatic Therapies (2023) · cites this paper as [64]
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- Authors
- Haeberlein, S. B., von Hehn, C., Tian, Y., Chalkias, S., Muralidharan, K. K., Chen, T., Wu, S., Skordos, L., Nisenbaum, L., Rajagovindan, R., Dent, G., Harrison, K., Nestorov, I., Zhu, Y., Mallinckrodt, C., & Sandrock, A.
- Affiliations
- Biogen (United States) (US)
- Biogen Cambridge MA USA
- Corresponding author
- Haeberlein, Samantha Budd
- ORCID
- Venue
- Alzheimer's & Dementia
- Publisher
- Wiley
- Published
- 2020-12
- Volume
- 16
- Issue
- S9
- ISSN
- 1552-5260 (ISSN-L)
- 1552-5279
- OpenAlex
- W3111988300
- Cited by
- 81
- References
- 0
- Citations by year
- 2026: 4 · 2025: 10 · 2024: 6 · 2023: 7 · 2022: 31 · 2021: 16 · 2020: 6
- FWCI
- 9.02
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alzheimer s & Dementia (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- aducanumab, early Alzheimer's disease
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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